Identity
- Trade Name
- NIO NEXT GENERATION IO FDA UDI
- Generic Name
- First aid absorbent pad/bandage FDA UDI
- Device Name
- NIO FIXATION DRESSING FDA UDI
- Model / Reference
- 1 FDA UDI
- Description
- NIO FIXATION DRESSING FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850026832105 FDA UDI
- FDA Product Code
- KMK FDA UDI
- GMDN Term
- First aid absorbent pad/bandage FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 880.5210 FDA UDI
- Commercial Distribution
- 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
No
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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: First aid absorbent pad/bandage
Nio Next Generation Io by Einstein Works, Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as First aid absorbent pad/bandage.
- ProStat — Prostat First Aid, LLC · Class I
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- Medi-First Plus Sterile Gauze Pads 3 x 3 (25 count) — Medique Products · Class I
- FCP Bandage — FIRST CARE PRODUCTS LTD · Class I
- Medi-First Plus Sterile Gauze Pads 2 x 2 (25 count) — Medique Products · Class I
- H-Bandage Compression Dressing - Rolled — H & H Medical Corporation · Class I
- EMSRUN — Anji Hengfeng Sanitary Material Co., Ltd · Class I
- RHINO RESCUE — Wuxi Emsrun Technology Co., Ltd. · 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
- Einstein Works, Llc
Sources (1)
- FDA UDI 9a8916bc-cd49-4c80-bc7a-3688efaaf097 33 fields · synced May 30, 2026