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Transwarmer Infant Transport Mattress
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref 20421Model 20418
Identity
- Trade Name
- TransWarmer® EUDAMEDTRANSWARMER INFANT TRANSPORT MATTRESS FDA UDI
- Generic Name
- Reactive-gel heating pad FDA UDI
- Device Name
- WarmGel® Infant Heel Warmer with Lift and Stick Tape EUDAMEDTRANSWARMER® INFANT TRANSPORT MATTRESS FDA UDI
- Model / Reference
- 20421 EUDAMEDFDA UDI20418 EUDAMED
- Description
- TRANSWARMER® INFANT TRANSPORT MATTRESS FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00888937025767 EUDAMEDFDA UDI
- Basic UDI-DI
- 0888937TD070ZQ EUDAMED
- 510(k) Number
- K934631 FDA UDI
- FDA Product Code
- IMD FDA UDI
- EMDN Code
- Z12080407 NEONATAL RADIANT WARMERS EUDAMED
- GMDN Term
- Reactive-gel heating pad FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 890.5710 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Conditional FDA UDI
Category: Reactive-gel heating pad
Transwarmer Infant Transport Mattress by CooperSurgical, Inc. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Reactive-gel heating pad.
- Mibest — Beijing Choice Electronic Technology Co., Ltd. · Class II
- Mibest — Beijing Choice Electronic Technology Co., Ltd. · Class II
- PORTA-WARM — Cardinal Health 200, LLC · Class I
- WARMGEL INSTANT HEAT PACK - Large — CooperSurgical, Inc. · Class I
- Cooper Surgical INFANT HEEL WARMER — CooperSurgical, Inc. · Class I
- fisherbrand Disposable Gel Infant Heel Warmer — CooperSurgical, Inc. · Class I
- WARMGEL INFANT HEEL WARMER — CooperSurgical, Inc. · Class I
- fisherbrand Disposable Liquid Infant Heel Warmer — CooperSurgical, Inc. · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- CooperSurgical, Inc.
Sources (2)
- FDA UDI 00c99895-4299-41f2-b163-324f57d8a465 34 fields · synced Aug 3, 2026
- EUDAMED 289a9d9a-5415-477d-b33e-fb24739d2586 61 fields · synced Aug 3, 2026