Identity
- Trade Name
- Cordguard® FDA UDI
- Generic Name
- Umbilical cord blood collection set FDA UDI
- Device Name
- Disposable umbilical cord clamp, cut, and blood collection device. FDA UDI
- Model / Reference
- II FDA UDI
- Description
- Disposable umbilical cord clamp, cut, and blood collection device. FDA UDI
Identifiers
- Catalog Number
- CRD-201 FDA UDI
- Primary DI / UDI-DI
- H671CRD2010 FDA UDI
- 510(k) Number
- K954619 FDA UDI
- FDA Product Code
- KNA FDA UDI
- GMDN Term
- Umbilical cord blood collection set FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 884.4530 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Umbilical cord clamp, single-useUmbilical cord blood collection set
Cordguard® by Utah Medical Products, Inc. — 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
- Utah Medical Products, Inc.
Sources (1)
- FDA UDI 78297a2c-1ea7-434d-ba01-50e69df6c41f 36 fields · synced Jun 9, 2026