Identity
- Trade Name
- Custom Healthcare Systems Inc. FDA UDI
- Generic Name
- Infant care kit FDA UDI
- Model / Reference
- UNC-9538 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00811870030536 FDA UDI
- FDA Product Code
- OKV FDA UDI
- GMDN Term
- Infant care kit FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 884.4520 FDA UDI
- 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
Yes
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Ethylene Oxide FDA UDI
Category: Infant care kit
Custom Healthcare Systems Inc. by Manus Medical, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 | Class II | Pending data |
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Manufacturer
- Manufacturer
- Manus Medical, LLC
Sources (1)
- FDA UDI a0e79f77-350b-44f0-a48c-5054ee269a0a 32 fields · synced Jun 8, 2026