FDA.reportPublic FDA data

VitalPatch Adhesive Overlay

Primary DI
00850490007283
Brand
VitalPatch Adhesive Overlay
Company
Vital Connect, Inc.
Model
3801-01
Catalog number
3801-01
Device description
VitalPatch Adhesive Overlay
Published
2019-03-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
00850490007290PackageGS120In Commercial Distribution
00850490007283PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850490007290008504900072908504900072900850490007290
00850490007283008504900072838504900072830850490007283

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
944642730
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850490007344VitalPatch 2.03037-013047-012019-07-25
00850490007511Holter Kit (Wi-Fi Only)2400-012400-012023-08-31
00850490007481VistaPhone8303-038303-032023-03-31
00850490007504VistaPhone Compact Cardiac Monitoring Kit1500-011400-022023-03-31
00850490007467VistaPhone8303-028303-022021-01-15
00850490007252Vista Solution® 30-day Monitoring Kit9430-019430-012020-11-04
00850490007269Vista Solution® 10-day Evaluation Kit9410-019410-012020-11-04
00850490007313Vista Solution® 2.0 10-day Evaluation Kit9510-019510-012020-11-04
00850490007368VistaTablet™ 2.0 RELAY (W/O VCI Box)8102-018102-012020-11-04
00850490007238VitalPatch 2.03037-013037-012020-11-03
00850490007375VistaCenter6200-036200-032020-11-02
00850490007382VistaPoint Software User Interface6100-036100-032020-11-02
00850490007399VistaTablet8103-018103-012020-11-02
00850490007412Vista Solution 3 10-day Evaluation Kit961096102020-11-02
00850490007429VistaTablet8203-018203-012020-11-02
00850490007436VistaPhone8303-018303-012020-11-02
00850490007443VitalConnect 14-day Cardiac Monitoring Kit1400-021400-022020-11-02
00850490007450VitalPatch® RTM 4007-014007-012020-11-02
00850490007207VistaTablet8101-018101-012018-08-16
00850490007290VitalPatch Adhesive Overlay3801-013801-012019-03-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
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