FDA.reportPublic FDA data

R&D Batteries, Inc.

Primary DI
00810149090301
Brand
R&D Batteries, Inc.
Company
R & D Batteries, Inc.
Model
5038
Device description
8.4 Volt 3.0Ah 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
ETNSTIMULATOR, NERVE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ETNStimulator, NerveEar, Nose, Throat2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K933491000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K933491000R AND D BATTERIES, INC. PART NOS. 5038 & 5347R & D Batteries, Inc.1993-11-19ETN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810149090301PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810149090301008101490903018101490903010810149090301

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
00763000821777NIM EssenceMEDTRONIC XOMED, INC.ETN2026-06-07
00763000821784NIM EssenceMEDTRONIC XOMED, INC.ETN2026-06-07
00763000821791NIM EssenceMEDTRONIC XOMED, INC.ETN2026-06-07
00763000821807NIM EssenceMEDTRONIC XOMED, INC.ETN2026-06-07
00763000821814NIM EssenceMEDTRONIC XOMED, INC.ETN2026-06-07
08681823002772Bioscope Neuromonitor DeviceBIOSYS BIYOMEDIKAL MUHENDISLIK SANAYI VE TICARET ANONIM SIRKETIETN2026-06-03
20199150023862N/AMEDTRONIC XOMED, INC.ETN2026-02-16
20199150023879N/AMEDTRONIC XOMED, INC.ETN2026-02-16
20199150023886N/AMEDTRONIC XOMED, INC.ETN2026-02-16
B006NVHS102NONENeurovision Medical Products, Inc.ETN2025-12-18
B006HGELS102NONENeurovision Medical Products, Inc.ETN2025-02-12
B006NVPS2Nerveäna+®Neurovision Medical Products, Inc.ETN2025-02-11
20763000842547Bipolar Stimulating ProbeMEDTRONIC XOMED, INC.ETN2024-10-26
20763000842554Bipolar Stimulating ProbeMEDTRONIC XOMED, INC.ETN2024-10-26
20763000842561Bipolar Stimulating ProbeMEDTRONIC XOMED, INC.ETN2024-10-26
10887482176853BovieASPEN SURGICAL PRODUCTS, INC.ETN2024-08-27
08720791376451Technomed EuropeTechnomed Engineering B.V.ETN2024-05-06
08720791376475Technomed EuropeTechnomed Engineering B.V.ETN2024-05-06
08720791376482Technomed EuropeTechnomed Engineering B.V.ETN2024-05-06
08720791373634NeuroradiumTechnomed Engineering B.V.ETN2024-02-12
08720791373665NeuroradiumTechnomed Engineering B.V.ETN2024-02-12
B006NVPTKITC3P6WSF52Nerveana+®Neurovision Medical Products, Inc.ETN2024-02-01
B006NVPTKITC3P7WSF52Nerveana+®Neurovision Medical Products, Inc.ETN2024-02-01
B006NVPTKITC3P8WSF52Nerveana+®Neurovision Medical Products, Inc.ETN2024-02-01
B006NVPTKITDCLD52Nerveana+®Neurovision Medical Products, Inc.ETN2024-02-01
B006NVPTKITDCLWF52Nerveäna+®Neurovision Medical Products, Inc.ETN2024-02-01
B006NVPTKITDCSD52Nerveana+®Neurovision Medical Products, Inc.ETN2024-02-01
B006NVPTKITDCSWF52Nerveäna+®Neurovision Medical Products, Inc.ETN2024-02-01
B006NVPMK1Nerveäna+®Neurovision Medical Products, Inc.ETN2024-02-01
B006NVPSTST2Nerveäna+®Neurovision Medical Products, Inc.ETN2024-02-01