FDA.reportPublic FDA data

R&D Batteries, Inc.

Primary DI
00810149095702
Brand
R&D Batteries, Inc.
Company
R & D Batteries, Inc.
Model
6398
Device description
13.5 Volt 2.0Ah Alkaline
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
FLLThermometer, electronic, clinical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FLLContinuous Measurement ThermometerGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K951282000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K951282000R&D BATTERIES, INC. PART NUMBERS 5039, 5052, 5056 AND 5061R & D Batteries, Inc.1995-08-18FLL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810149095702PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810149095702008101490957028101490957020810149095702

GMDN Terms#

Term, Definition table
TermDefinition
Primary batteryA non-rechargeable set of electrochemical cells, or a single cell, designed to store chemical energy and release it in the form of electrical energy to provide power for active implantable medical devices or external medical instruments, for backup power for programmable devices that must retain electronic information, or to power portable or other medical devices when it is not possible or convenient to use the line supply. The device includes terminals and may include a case. The size, shape, and chemical composition of the device should be specified according to the requirements in "IEC 60086-1 Primary batteries - Part 1: General", or the latest version of this standard.

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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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B3945600013020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.FLL2026-05-27
B3945700048010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.FLL2026-05-27
B3945700048020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.FLL2026-05-27
B3945700048030WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.FLL2026-05-27
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B3945700068020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.FLL2026-05-27
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