Blood And Urine Collection Kit (Excludes Hiv Testing)
Regulation 864.3250
0510(k)s in 12 months (0 all time)
9recalls in 12 months (29 all time)
0recalls that name a 510(k)
Top companies in OIB
| Company | 510(k)s | Recalls |
|---|---|---|
| MEDLINE INDUSTRIES, LP - Northfield | 0 | 17 |
| Medline Industries, LP | 0 | 8 |
| Centurion Medical Products Corporation | 0 | 3 |
| LSL Healthcare Inc. | 0 | 1 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 14, 2026 | Medline Industries, LP Medline Convenience Kits:
1) DYNDB3086D, Catalog Number: DYNDB3086D;
2) DYNDB3100, Catalog Number: DYNDB3100;
3) DYNDH1619A, Catalog Number: DYNDH1619A;
4) DYNDH1620A, Catalog Number: DYNDH1620A;
Open, Classified |
OIB | None listed |
| Aug 31, 2026 | Medline Industries, LP Medline Convenience Kits:
1) BLOOD DRAW KIT, Catalog Number: DYLAB1081;
2) WHOLE BLOOD PHLEBOTOMY KIT, Catalog Number: DYNDB3005D;
3) QP KIT, Catalog Number: DYNDB3005F;
4) DOUBLE RED CELL PHLEBOTO Open, Classified |
OIB | None listed |
| Aug 31, 2026 | Medline Industries, LP Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators
ADULT BLOOD CULTURE KIT
DYNDH1444D
BLOOD CULTR KT DIVRSN DEVICE
DYNDH1866
BLOOD CULTURE KIT
DYNDH1462B
DYNDH1622C
D Open, Classified |
OIB | None listed |
| Aug 31, 2026 | Medline Industries, LP Medline Convenience Kits:
1) IVS BLOOD CULTURE KIT, Model Number: DYNDH1920;
2) IVS BLOOD CULTURE KIT, Model Number: DYNDH1920A Open, Classified |
OIB | None listed |
| May 7, 2026 | Medline Industries, LP Medline Convenience Kits:
1) WMC I D PACK-LF, Model Number: DYNJ50806L Open, Classified |
OIB | None listed |
| Apr 30, 2026 | Medline Industries, LP Medline medical convenience kits, containing Webcol Large Alcohol Prep Pads, labeled as:
1. BLOOD CULTURE KIT, Medline Kit SKU DYNDH1520;
2. BLOOD DRAW KIT, Medline Kit SKU EBSI1317. Open, Classified |
OIB | None listed |
| Apr 22, 2026 | LSL Healthcare Inc. LSL Healthcare, Foley Urine Collection Kit, Model/Catalog Number: 1555 Open, Classified |
OIB | None listed |
| Feb 17, 2026 | Medline Industries, LP Medline Convenience Kits:
1) WMC I D PACK-LF, Model Number: DYNJ50806L Open, Classified |
OIB | None listed |
| Feb 9, 2026 | Medline Industries, LP Medline medical convenience kits packaged as: BLOOD CULTURE KIT NS, Kit SKU DYNDH2088 Open, Classified |
OIB | None listed |
| Jul 21, 2025 | MEDLINE INDUSTRIES, LP - Northfield Medline Convenience Kits, containing BD ChloraPrep Clear - 1mL Applicator, labeled as:
1) BLOOD CULTURE KIT, REF DYNDH1462B;
2) BLOOD CULTURE KIT, REF DYNDH1622C;
3) BLOOD CULTR KT DIVRSN DEVICE, Open, Classified |
OIB | None listed |
| Sep 6, 2024 | MEDLINE INDUSTRIES, LP - Northfield Medline Convenience kits, labeled as:
1) BLOOD CULTURE COLLECTION KIT, Pack Number BP115;
2) NICU CNTRL LINE BLOOD DRAW KIT, Pack Number DYLAB1044;
3) NEURO ANGIO PACK, Pack Number DYNDA1431A;
4 Open, Classified |
OIB | None listed |
| Aug 28, 2024 | MEDLINE INDUSTRIES, LP - Northfield Medline procedural kits labeled as:
ARTHROGRAPH TRAY, Pack Number MNS12670A Open, Classified |
OIB | None listed |
| Aug 27, 2024 | MEDLINE INDUSTRIES, LP - Northfield Medline procedure packs containing Shenli syringes, labeled as follows:
NEURO ANGIO PACK, Pack Number DYNDA1431A Open, Classified |
OIB | None listed |
| Mar 29, 2024 | MEDLINE INDUSTRIES, LP - Northfield Centurion STERILE BLOOD COLLECTION TUBE,10ML, Product Code 6430ST Open, Classified |
OIB | None listed |
| Feb 25, 2024 | MEDLINE INDUSTRIES, LP - Northfield Centurion Kits, trays, and packs labeled as follows:
MAINTENANCE FLUSH KIT/BLOOD DRAW, REF DT19335A Open, Classified |
OIB | None listed |
| Feb 25, 2024 | MEDLINE INDUSTRIES, LP - Northfield Medline Kits, trays, and packs labeled as follows:
a) BLOOD DRAW KIT, REF DYNDV2183A;
b) LCPH LAB DRAW KIT, REF DYNDH1641A;
c) LCPH LAB DRAW KIT, REF DYNDH1641AH;
d) OB LAB COLLECTION KIT, REF DY Open, Classified |
OIB | None listed |
| Feb 25, 2024 | MEDLINE INDUSTRIES, LP - Northfield Centurion Kits, trays, and packs labeled as follows: MAINTENANCE FLUSH KIT/BLOOD DRAW, REF DT19335A Open, Classified |
OIB | None listed |
| Feb 1, 2024 | MEDLINE INDUSTRIES, LP - Northfield MEDLINE BLOOD CULTURE TRAY ADULT, Reorder Number DYNDH1194A Open, Classified |
OIB | None listed |
| Feb 1, 2024 | MEDLINE INDUSTRIES, LP - Northfield MEDLINE BLOOD CULTURE KIT, Reorder Number DYNDH1622C Open, Classified |
OIB | None listed |
| Feb 1, 2024 | MEDLINE INDUSTRIES, LP - Northfield MEDLINE BLOOD CULTURE KIT, Reorder Number DYNDH1723 Open, Classified |
OIB | None listed |
| Feb 1, 2024 | MEDLINE INDUSTRIES, LP - Northfield MEDLINE BLOOD CULTURE COLLECTION KIT, Reorder Number DYNDH1626B Open, Classified |
OIB | None listed |
| Feb 1, 2024 | MEDLINE INDUSTRIES, LP - Northfield MEDLINE BLOOD CULTURE COLLECTION KIT, Reorder Number DYNDH1714A Open, Classified |
OIB | None listed |
| Feb 1, 2024 | MEDLINE INDUSTRIES, LP - Northfield MEDLINE BLOOD CULTURE BOTTLE KIT, Reorder Number DYNDH1738A Open, Classified |
OIB | None listed |
| Feb 1, 2024 | MEDLINE INDUSTRIES, LP - Northfield MEDLINE ADULT BLOOD CULTURE KIT, Reorder Number DYNDH1694A Open, Classified |
OIB | None listed |
| Nov 16, 2023 | MEDLINE INDUSTRIES, LP - Northfield BLOOD CULTURE KIT, REF DYNDH1647B Open, Classified |
OIB | None listed |
| Feb 10, 2023 | MEDLINE INDUSTRIES, LP - Northfield Surgical convenience kits labeled as:
MEDLINE LCPH LAB DRAW KIT, Reorder Number DYNDH1641A Open, Classified |
OIB | None listed |
| Dec 11, 2019 | Centurion Medical Products Corporation Centurion- Port Draw Kit
KNV30 PORT DRAW KIT Terminated |
OIB | None listed |
| Dec 11, 2019 | Centurion Medical Products Corporation Centurion-BLOOD CULTURE COLLECTION KIT
BP115 BLOOD CULTURE COLLECTION KIT Terminated |
OIB | None listed |
| Jul 15, 2019 | Centurion Medical Products Corporation Maintenance Flush Kit/Blood Draw
Product Code: DT19335 Terminated |
OIB | None listed |
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