Identity
- Trade Name
- R&D Batteries, Inc. FDA UDI
- Generic Name
- Primary battery FDA UDI
- Device Name
- 3.6 Volt / 1.2Ah Lithium FDA UDI
- Model / Reference
- 6301 FDA UDI
- Description
- 3.6 Volt / 1.2Ah Lithium FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00810149095184 FDA UDI
- 510(k) Number
- K942018 FDA UDI
- FDA Product Code
- FCO FDA UDI
- GMDN Term
- Primary battery 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
No
FDA UDI
Over-the-Counter
Yes
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Primary battery
R&D Batteries, Inc. by R & D Batteries, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K942018 also covers:
- R&D Batteries, Inc. — R & D BATTERIES, INC.
- R&D Batteries, Inc. — R & D BATTERIES, INC.
- R&D Batteries, Inc. — R & D BATTERIES, INC.
- R&D Batteries, Inc. — R & D BATTERIES, INC.
- R&D Batteries, Inc. — R & D BATTERIES, INC.
- R&D Batteries, Inc. — R & D BATTERIES, INC.
- R&D Batteries, Inc. — R & D BATTERIES, INC.
- R&D Batteries, Inc. — R & D BATTERIES, INC.
- R&D Batteries, Inc. — R & D BATTERIES, INC.
- R&D Batteries, Inc. — R & D BATTERIES, INC.
- R&D Batteries, Inc. — R & D BATTERIES, INC.
- R&D Batteries, Inc. — R & D BATTERIES, INC.
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
- R & D Batteries, Inc.
Sources (1)
- FDA UDI 713442b0-c612-4aff-80df-cdfc2e68b98b 35 fields · synced Jun 8, 2026