Identity
- Trade Name
- NiBP, Disposable, Infant, 10-15cm FDA UDI
- Generic Name
- Blood pressure cuff, reusable FDA UDI
- Device Name
- NiBP, Disp, Infant, 10 - 15cm FDA UDI
- Model / Reference
- Cuff, NiBP, Disp, Infant, 10-15cm FDA UDI
- Description
- NiBP, Disp, Infant, 10 - 15cm FDA UDI
Identifiers
- Catalog Number
- 989803170431 FDA UDI
- Primary DI / UDI-DI
- 00884838034280 FDA UDI
- FDA Product Code
- DXN FDA UDI
- GMDN Term
- Blood pressure cuff, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1130 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
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
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Conditional FDA UDI
NiBP, Disposable, Infant, 10-15cm by Philips DS North America LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Philips DS North America LLC
Sources (1)
- FDA UDI d8e029ad-544b-4829-a55e-f506bb20ee71 37 fields · synced Jun 8, 2026