FDA.reportPublic FDA data

Ultium

Primary DI
00816271020681
Brand
Ultium
Company
Noraxon U.S.A., Inc.
Model
874D
Device description
Torso Adapter Tape
Published
2026-03-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
KGXTape And Bandage, Adhesive

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KGXTape And Bandage, AdhesiveGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816271020681PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816271020681008162710206818162710206810816271020681

GMDN Terms#

Term, Definition table
TermDefinition
Kinesiology/electromyographic sensor setA collection of patient-worn devices consisting of both an electromyographic sensor and motion-based sensor intended to be used in a clinical setting as part of a system (e.g., virtual-display rehabilitation system, biomechanical analysis system) to provide non-gravity-compensating analysis, biofeedback, and/or interactive rehabilitation of neuromuscular/musculoskeletal conditions. It is typically intended to be used with a computer, interface devices, and software (not included).

Regulatory Flags#

DUNS number
611243809
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00816271020377Noraxon2622026-03-30
00816271020391Ultium810C2026-03-30
00816271020407Ultium8022026-03-30
00816271020414Ultium8082026-03-30
00816271020421Ultium8112026-03-30
00816271020438Ultium8172026-03-30
00816271020445Ultium8202026-03-30
00816271020452Ultium8212026-03-30
00816271020469Ultium8242026-03-30
00816271020476Ultium8262026-03-30
00816271020483Ultium8292026-03-30
00816271020490Ultium8422026-03-30
00816271020506Ultium842X2026-03-30
00816271020513Ultium842Y2026-03-30
00816271020520Ultium8522026-03-30
00816271020537Ultium874E2026-03-30
00816271020698Ultium874HL2026-03-30
00816271020735Core8162026-03-30
00816271020766UltiumAPP012026-03-30
00816271020773Core8842026-03-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00050428344095CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDKGX2026-10-16
20665973032423DukalDukal LLCKGX2026-10-14
20665973032430DukalDukal LLCKGX2026-10-14
00050428142677CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDKGX2026-10-10
00050428143124CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDKGX2026-10-10
00050428340523CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDKGX2026-10-10
00050428340936CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDKGX2026-10-10
00050428341308CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDKGX2026-10-10
00050428342053CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDKGX2026-10-10
00050428342121CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDKGX2026-10-10
00050428342602CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDKGX2026-10-10
00050428346396CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDKGX2026-10-10
00050428347133CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDKGX2026-10-10
00389152744957Adhesive Sleeve, 10 Pack, Tandem MobiTandem Diabetes Care, Inc.KGX2026-10-07
00389152745459Adhesive Sleeve, 2 Pack, Tandem MobiTandem Diabetes Care, Inc.KGX2026-10-07
00197998029844Solventum™ Micropore™Solventum Germany GmbHKGX2026-10-05
00311917088556WalgreensWALGREEN CO.KGX2026-09-30
08859922800036EquateWAL-MART STORES, INC.KGX2026-09-30
08859922800043EquateWAL-MART STORES, INC.KGX2026-09-30
08859922800050EquateWAL-MART STORES, INC.KGX2026-09-30
08859922800067EquateWAL-MART STORES, INC.KGX2026-09-30
00850087488877CeeportCEEPORT INC.KGX2026-09-29
00197998095641Transpore™Solventum US LLCKGX2026-09-25
00197998095672Transpore™Solventum US LLCKGX2026-09-25
00197998095702Transpore™Solventum US LLCKGX2026-09-25
00197998095733Transpore™Solventum US LLCKGX2026-09-25
00197998095788Transpore™Solventum US LLCKGX2026-09-25
00197998103612Transpore™Solventum US LLCKGX2026-09-25
00197998103636Transpore™Solventum US LLCKGX2026-09-25
00197998164118Transpore™Solventum US LLCKGX2026-09-25