Identity
- Trade Name
- NFLOW INFANT BONNET, DARK GREY, SIZE 1 FDA UDI
- Generic Name
- Infant head cap FDA UDI
- Device Name
- NFLOW INFANT BONNET, DARK GREY, SIZE 1 FDA UDI
- Model / Reference
- 4707001 FDA UDI
- Description
- NFLOW INFANT BONNET, DARK GREY, SIZE 1 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05030267088454 FDA UDI
- FDA Product Code
- JAY FDA UDI
- GMDN Term
- Infant head cap FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 868.5280 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
Yes
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
Category: Infant head cap
Nflow Infant Bonnet, Dark Grey, Size 1 by Intersurgical Incorporated — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Infant head cap.
- DeRoyal — DEROYAL INDUSTRIES, INC. · Class I
- Bioseal Inc. — BIOSEAL · Class I
- NFLOW INFANT BONNET, BLUE, SIZE 3 — Intersurgical Incorporated · Class I
- NFLOW INFANT BONNET, WHITE, SIZE 000 — Intersurgical Incorporated · 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 | Class I | Pending data |
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Manufacturer
- Manufacturer
- Intersurgical Incorporated
Sources (1)
- FDA UDI 7bbbada2-d689-4c2d-852a-c2cf66777664 34 fields · synced Jun 1, 2026