Identity
- Trade Name
- Battery Pack, Single Use, PDCMF, Tadiran FDA UDI
- Generic Name
- Disposable battery pack FDA UDI
- Model / Reference
- PDCMF-BP-001 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00856482008283 FDA UDI
- FDA Product Code
- GEY FDA UDIGXL FDA UDI
- GMDN Term
- Disposable battery pack FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4820 FDA UDI882.4900 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Disposable battery pack
Battery Pack, Single Use, PDCMF, Tadiran by Pro-Dex, Inc. — Class I — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Disposable battery pack.
- Battery AED 3 — Zoll Medical Corporation · Class III
- Bioseal Inc. — BIOSEAL · Class I
- IQ SYSTEM — BIOMET MICROFIXATION, INC · Class I
- AED Battery Exchange — AED Battery Exchange, LLC · Class III
- Insurgical, Inc. — Insurgical, Inc. · Class I
- LEVEL ONE, STERILE — KLS-Martin L.P. · Class I
- Bioseal Inc. — BIOSEAL · Class I
- TiMesh® — Medtronic PS Medical · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class I | Unknown |
| 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
- Pro-Dex, Inc.
Sources (2)
- FDA UDI b04d1a9d-b241-489e-90ef-b4b6e1469a81 33 fields · synced May 30, 2026
- EUDAMED 1 fields · synced May 29, 2026