Identity
- Trade Name
- Kit, C-Section Add On Wellstar FDA UDI
- Generic Name
- Infant care kit FDA UDI
- Device Name
- Kit, C-Section Add On Wellstar FDA UDI
- Model / Reference
- KT170A FDA UDI
- Description
- Kit, C-Section Add On Wellstar FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00817395023985 FDA UDI
- GMDN Term
- Infant care kit FDA UDI
Classification
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Infant care kit
Kit, C-Section Add On Wellstar by Packroom Llc — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Infant care kit.
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- Safety 1st — DOREL JUVENILE GROUP, INC. · Class II
- Safety 1st — DOREL JUVENILE GROUP, INC. · Class II
- Summer Infant — SUMMER INFANT (USA), INC. · Class II
- Dr. Brown's — Dr. Brown's Company · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | N/A | Pending data |
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Manufacturer
- Manufacturer
- Packroom Llc
Sources (1)
- FDA UDI 25bd1e39-7b56-42cd-b539-c38b06eace2c 33 fields · synced May 31, 2026