510(k) K912715 ยท IMD Pack, Hot Or Cold, Disposable
INSTANT WARM GEL PACK
| Applicant | Prism Technologies, Inc., Chicago IL, US |
| Decision | Substantially Equivalent, Oct 2, 1991 |
| Received | Jun 18, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K912715
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 19, 2015 | CooperSurgical, Inc. CooperSurgical Infant Heel Gel Warmers, P/N 20418
CooperSurgical The Infant Heal Warmer, P/N 2440
To provide gentle heat to increase blood flow and enhance
infant blood sample collection Terminated |
IMD | None listed |
| Mar 19, 2015 | CooperSurgical, Inc. Fisher Brand Gel Infant Heel Gel Warmers,
Cat. No.: 22-024647
Fisher Brand Liquid Infant Heel Warmer, Cat. No: 22-024646
To provide gentle heat to increase blood flow and enhance infant blood sample Terminated |
IMD | None listed |
| Mar 19, 2015 | CooperSurgical, Inc. MediChoice WarmGel Infant Heel Warmer, Item # 1643069911
MediChoice Liquid Infant Heel Warmer, Item # 1643069912
Single Use and Disposable.
Distributed by: Owens & Minor.
To provide gentle heat t Terminated |
IMD | None listed |
| Mar 19, 2015 | CooperSurgical, Inc. NovaPlus Brand Warm Gel Infant Heel Gel Warmer, Item # V6391
NovaPlus Brand Liquid Heal Warmer. Item #V6393
Single Use and Disposable
To provide gentle heat to increase blood flow and enhance infant Terminated |
IMD | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.