FDA.reportPublic FDA data

Gentell FixTape (2x11 yards)

Primary DI
00361554002118
Brand
Gentell FixTape (2x11 yards)
Company
Gentell, LLC
Model
GEN-10600
Catalog number
GEN-10600
Published
2025-03-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

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
00361554002118PrimaryGS10
00361554002101Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00361554002118003615540021183615540021180361554002118
00361554002101003615540021013615540021010361554002101

GMDN Terms#

Term, Definition table
TermDefinition
Dressing-fixation skin adhesive tape, non-siliconeA long and narrow flexible band of non-silicone-based material (e.g., fabric, plastic, paper) coated on one or both sides with a pressure-sensitive adhesive, intended to non-invasively adhere to the skin surface to fix a dressing in place or attach objects (e.g., catheter, lamp); it might have hypoallergenic and/or waterproof properties. This is a single-use device.

Regulatory Flags#

DUNS number
170967876
Device count
64
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00361554003870GentellGEN-158182024-11-29
00361554003818GentellGEN-154142024-11-29
00361554003412Silicone Superabsorbent Bordered Dressing GEN-196402026-05-19
00361554003436Silicone Superabsorbent Bordered Dressing GEN-196602026-05-19
00361554003450Silicone Superabsorbent Bordered Dressing GEN-196802026-05-19
00361554007212GentellGEN-130222025-08-26
00361554007243GentellGEN-130442025-08-26
00361554007274GentellGEN-130662025-08-26
00361554007229GentellGEN-130222025-08-26
00361554007250GentellGEN-130442025-08-26
00361554007182GentellGEN-130662025-08-26
15056860000034Gentell Hydrogel Sheet DressingGEN-112402025-08-21
15056860000041Gentell Hydrogel Sheet DressingGEN-114702025-08-21
15056860000058Gentell Hydrogel Sheet DressingGEN-117002025-08-21
00361554001050GentellGEN-130202025-08-21
00361554001081GentellGEN-130402025-08-21
00361554001111GentellGEN-130602025-08-21
00361554003375GentellGEN-130202025-08-21
00361554001098GentellGEN-130402025-08-21
00361554001128GentellGEN-130602025-08-21

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Primary DI, Brand, Company table
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00197998041556Solventum™ Micropore™Solventum US LLCKGX2026-10-23
00197998042782Solventum™ Micropore™Solventum US LLCKGX2026-10-23
00197998054129Solventum™ Micropore™Solventum US LLCKGX2026-10-23
00197998054150Solventum™ Micropore™Solventum US LLCKGX2026-10-23
00197998054181Solventum™ Micropore™Solventum US LLCKGX2026-10-23
00197998054211Solventum™ Micropore™Solventum US LLCKGX2026-10-23
00197998054242Solventum™ Micropore™Solventum US LLCKGX2026-10-23
00197998054273Solventum™ Micropore™Solventum Germany GmbHKGX2026-10-23
00197998054327Solventum™ Micropore™Solventum Germany GmbHKGX2026-10-23
00197998054358Solventum™ Micropore™Solventum Germany GmbHKGX2026-10-23
00197998054396Solventum™ Micropore™Solventum Germany GmbHKGX2026-10-23
00194346726660EquateWAL-MART STORES, INC.KGX2026-10-22
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