FDA.reportPublic FDA data

R&D Batteries, Inc.

Primary DI
00810149090837
Brand
R&D Batteries, Inc.
Company
R & D Batteries, Inc.
Model
5124
Device description
2.4 Volt 1.8Ah NiCd
Published
2024-01-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HLJOphthalmoscope, battery-powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HLJOphthalmoscope, Battery-PoweredOphthalmic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K942034000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K942034000R&D BATTERIES, PART NOS. 5135, 5097, 5444, AND 5502R & D Batteries, Inc.1994-06-03HLJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810149090837PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810149090837008101490908378101490908370810149090837

GMDN Terms#

Term, Definition table
TermDefinition
Portable/mobile rechargeable battery packA group of rechargeable batteries held within a holder, container, or mobile cart/trolley intended to provide temporary electrical energy to operate a medical device, typically when it is not possible, intentional, or convenient to connect the device being powered to a mains electricity (AC-powered) electrical outlet; it might additionally have features to facilitate transport of the device being powered (e.g., push handles, storage shelves, mounting rails). It is typically used during a transport situation (e.g., a neonatal incubator) or to power a cordless device (e.g., an endoscopic device or a rechargeable battery-powered surgical drilling system handpiece). This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)950-1945info@rdbatteries.com

Regulatory Flags#

DUNS number
198457830
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810149098291R&D Batteries, Inc.67052026-04-01
00810149098277R&D Batteries, Inc.6703-A2026-03-13
00810149094422R&D Batteries, Inc.61912024-01-01
00810149098260R&D Batteries, Inc.6701-A2026-03-02
00810149098246R&D Batteries, Inc.6312-A2026-02-12
00810149098239R&D Batteries, Inc.6699-A2026-01-28
00810149098222R&D Batteries, Inc.66982026-01-20
00810149098215R&D Batteries, Inc.6697-A2025-12-15
00810149098208R&D Batteries, Inc.66962025-11-19
00810149098192R&D Batteries, Inc.6695-A2025-11-05
00810149098185R&D Batteries, Inc.6694-A2025-10-29
00810149098178R&D Batteries, Inc.6693-A2025-10-27
00810149098024R&D Batteries, Inc.66642025-08-27
00810149098093R&D Batteries, Inc.66852025-10-15
00810149098109R&D Batteries, Inc.66862025-10-15
00810149098116R&D Batteries, Inc.66872025-10-15
00810149098123R&D Batteries, Inc.66882025-10-15
00810149098130R&D Batteries, Inc.66892025-10-15
00810149098147R&D Batteries, Inc.66902025-10-15
00810149098055R&D Batteries, Inc.6580-A2025-10-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
M368122731LabtronGF HEALTH PRODUCTS, INC.HLJ2020-09-22
M368122741LabtronGF HEALTH PRODUCTS, INC.HLJ2020-09-22
00192896009509HEINE - BETA R HANDLESONTEC INSTRUMENTS, INC.HLJ2018-08-24
00192896009516HEINE - LITHIUM ION BATTERYSONTEC INSTRUMENTS, INC.HLJ2018-08-24
00192896009523HEINE MPACK MINI SONTEC INSTRUMENTS, INC.HLJ2018-08-24
00192896009530HEINE MPACK LL BATTERY PACK SONTEC INSTRUMENTS, INC.HLJ2018-08-24
00192896009547HEINE MPACK UNPLUGGED BATTERYSONTEC INSTRUMENTS, INC.HLJ2018-08-24
00192896009554HEINE MPACK UNPLUGGED BATTERYSONTEC INSTRUMENTS, INC.HLJ2018-08-24
00192896009561HEINE HC 50 CONNECTING CORDSONTEC INSTRUMENTS, INC.HLJ2018-08-24
00192896009578HEINE MPACK SONTEC INSTRUMENTS, INC.HLJ2018-08-24
00192896009585HEINE MPACK COMPLETESONTEC INSTRUMENTS, INC.HLJ2018-08-24
00192896009592HEINE LI-ION BATTERY SONTEC INSTRUMENTS, INC.HLJ2018-08-24
00634782089221Diagnostix™AMERICAN DIAGNOSTIC CORPHLJ2018-01-19
00634782089238Diagnostix™AMERICAN DIAGNOSTIC CORPHLJ2018-01-19
00634782089252Diagnostix™AMERICAN DIAGNOSTIC CORPHLJ2018-01-19
00634782089276Diagnostix™AMERICAN DIAGNOSTIC CORPHLJ2018-01-19
00634782089290Diagnostix™AMERICAN DIAGNOSTIC CORPHLJ2018-01-19
00634782089313Diagnostix™AMERICAN DIAGNOSTIC CORPHLJ2018-01-19
00634782089320Diagnostix™AMERICAN DIAGNOSTIC CORPHLJ2018-01-19
00634782088910Diagnostix™AMERICAN DIAGNOSTIC CORPHLJ2018-01-12
00634782088934Diagnostix™AMERICAN DIAGNOSTIC CORPHLJ2018-01-12
00634782088941Diagnostix™AMERICAN DIAGNOSTIC CORPHLJ2018-01-12
00634782088958Diagnostix™AMERICAN DIAGNOSTIC CORPHLJ2018-01-12
00634782088965Diagnostix™AMERICAN DIAGNOSTIC CORPHLJ2018-01-12
00634782088972Diagnostix™AMERICAN DIAGNOSTIC CORPHLJ2018-01-12
00634782088989Diagnostix™AMERICAN DIAGNOSTIC CORPHLJ2018-01-12
00634782088996Diagnostix™AMERICAN DIAGNOSTIC CORPHLJ2018-01-12
00634782087753Diagnostix™AMERICAN DIAGNOSTIC CORPHLJ2018-01-12
00634782087760Diagnostix™AMERICAN DIAGNOSTIC CORPHLJ2018-01-12
00634782087784Diagnostix™AMERICAN DIAGNOSTIC CORPHLJ2018-01-12