Panels › General, Plastic Surgery › Product code OJJ · Class 1
Burn Kit Without Drug
Regulation 878.4022
0510(k)s in 12 months (0 all time)
2recalls in 12 months (7 all time)
0recalls that name a 510(k)
Top companies in OJJ
| Company | 510(k)s | Recalls |
|---|---|---|
| MEDLINE INDUSTRIES, LP - Northfield | 0 | 3 |
| Medline Industries, LP | 0 | 2 |
| Certified Safety Mfg Inc | 0 | 1 |
| ROi CPS LLC | 0 | 1 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 7, 2026 | Medline Industries, LP Medline Convenience Kits:
1) BURN PACK, Model Number: DYNJ15668R;
2) BURN PACK-LF, Model Number: DYNJ42829B;
3) BURN CARE PACK-LF, Model Number: DYNJT3437 Open, Classified |
OJJ | None listed |
| Feb 17, 2026 | Medline Industries, LP Medline Convenience Kits:
1) BURN PACK, Model Number: DYNJ15668R;
2) BURN PACK-LF, Model Number: DYNJ42829B;
3) BURN CARE PACK-LF, Model Number: DYNJT3437 Open, Classified |
OJJ | None listed |
| Dec 5, 2024 | MEDLINE INDUSTRIES, LP - Northfield MEDLINE convenience kits labeled as:
1) BURN, REF CDS983465M;
2) BURN, REF CDS983465N;
3) BURN PACK, REF DYNJ63331D Open, Classified |
OJJ | None listed |
| Sep 6, 2024 | MEDLINE INDUSTRIES, LP - Northfield Medline Convenience kits, labeled as:
aa1) BURN PACK-LF, Pack Number DYNJ0781678S ;
2) BURN PACK , Pack Number DYNJ0976092P ;
3) BURN PACK-LF, Pack Number DYNJ42829B ;
4) BURN PACK , Pack Number Open, Classified |
OJJ | None listed |
| Oct 6, 2023 | ROi CPS LLC GS0008 2Y - Burn Pack - STL, Item Number 880082025 Open, Classified |
OJJ | None listed |
| Feb 6, 2023 | MEDLINE INDUSTRIES, LP - Northfield Sterile Procedural Trays, labeled as the following:
a. MAJOR CDS-LF
b. BURN PACK-LF
c. BURN PACK
d. SMALL BURN Open, Classified |
OJJ | None listed |
| Jun 26, 2017 | Certified Safety Mfg Inc Burn Sheet, sterile - 60" x 96". Included in First Aid Kits: 36M - Delmarva Power/ACE - w/Logo, Certified Safety Manufacturing logo, and sold blank.
product Usage:
Provides sterile environment to Terminated |
OJJ | None listed |
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