Identity
- Trade Name
- AED Power Bank Battery, Rechargeable FDA UDI
- Generic Name
- Endoscopic light source unit, battery-powered FDA UDI
- Device Name
- AED Power Bank Battery, Rechargeable FDA UDI
- Model / Reference
- K100 FDA UDI
- Description
- AED Power Bank Battery, Rechargeable FDA UDI
Identifiers
- Catalog Number
- K100 FDA UDI
- Primary DI / UDI-DI
- 00848657023108 FDA UDI
- FDA Product Code
- FEM FDA UDI
- GMDN Term
- Endoscopic light source unit, battery-powered FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 876.1500 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Endoscopic light source unit, battery-powered
AED Power Bank Battery, Rechargeable by National Advanced Endoscopy Devices, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Endoscopic light source unit, battery-powered.
- BR Surgical, LLC — BR SURGICAL LLC · Class II
- OTOPRONT — Happersberger Otopront GmbH · Class I
- Portable Light Source — OPTIM LLC · Class II
- Olympus — Olympus Winter & Ibe GmbH · Class II
- Olympus — Olympus Winter & Ibe GmbH · Class II
- PENTAX — HOYA CORPORATION · Class II
- HALOGEN LAMP — Olympus Medical Systems Corporation · Class II
- Portable Red LED Light Source — Stryker Corp. · Class II
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- National Advanced Endoscopy Devices, Inc.
Sources (1)
- FDA UDI 2e434109-9dea-4295-8870-fd67dfb7a43c 35 fields · synced Jun 1, 2026