Identity
- Trade Name
- NOVO Health Services, LLC FDA UDI
- Generic Name
- Basic pillowcase, reusable FDA UDI
- Device Name
- DT, PCase, White, COG FDA UDI
- Model / Reference
- 14000 FDA UDI
- Description
- DT, PCase, White, COG FDA UDI
Identifiers
- Catalog Number
- 14000 FDA UDI
- Primary DI / UDI-DI
- 00810019801358 FDA UDI
- 510(k) Number
- K152884 FDA UDI
- FDA Product Code
- FMW FDA UDI
- GMDN Term
- Basic pillowcase, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 880.6190 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Basic pillowcase, reusable
NOVO Health Services, LLC by Novo Health Services, Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K152884 also covers:
- NOVO Health Services, LLC — NOVO HEALTH SERVICES, LLC
- NOVO Health Services, LLC — NOVO HEALTH SERVICES, LLC
- NOVO Health Services, LLC — NOVO HEALTH SERVICES, LLC
- NOVO Health Services, LLC — NOVO HEALTH SERVICES, LLC
- NOVO Health Services, LLC — NOVO HEALTH SERVICES, LLC
- NOVO Health Services, LLC — NOVO HEALTH SERVICES, LLC
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 I | Pending data |
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Manufacturer
- Manufacturer
- Novo Health Services, Llc
Sources (1)
- FDA UDI ffbcb30c-d4cd-489d-b549-e334e95c34d4 36 fields · synced Jun 1, 2026