FDA.reportPublic FDA data

VitalPatch Adhesive Overlay

Primary DI
00850490007290
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
OTC
false
Sterile
false
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
Basic skin adhesive tapeA long and narrow flexible band of fabric, plastic, paper, or other material, 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 is not hypoallergenic or waterproof. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
944642730
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
00850490007283VitalPatch Adhesive Overlay3801-013801-012019-03-26
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850087488785CeeportCEEPORT INC.KGX2026-08-26
00850087488792CeeportCEEPORT INC.KGX2026-08-26
00197998149016Solventum™ Tegaderm™Solventum US LLCKGX2026-08-23
00197998149047Solventum™ Tegaderm™Solventum US LLCKGX2026-08-23
00197998149078Solventum™ Tegaderm™Solventum US LLCKGX2026-08-23
00197998149382Solventum™ Tegaderm™Solventum US LLCKGX2026-08-23
00197998149412Solventum™ Tegaderm™Solventum US LLCKGX2026-08-23
00197998149443Solventum™ Tegaderm™Solventum US LLCKGX2026-08-23
00197998149474Solventum™ Tegaderm™Solventum US LLCKGX2026-08-23
00197998149504Solventum™ Tegaderm™Solventum US LLCKGX2026-08-23
00197998185557Solventum™ Tegaderm™Solventum US LLCKGX2026-08-23
00029369133334McDavidShock Doctor, Inc.KGX2026-08-18
00050428143216CVSWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDKGX2026-08-18
069740214114323H MedicalWAL-MART STORES, INC.KGX2026-07-31
069740214114943H MedicalWAL-MART STORES, INC.KGX2026-07-31
06979191882112NanacareWAL-MART STORES, INC.KGX2026-07-31
06979191882228NanacareWAL-MART STORES, INC.KGX2026-07-31
06979191882242NanacareWAL-MART STORES, INC.KGX2026-07-31
06979191882273BadBuddyWAL-MART STORES, INC.KGX2026-07-31
06979191883591OKTAPEHTT Technologies, Inc.KGX2026-07-31
06979191883607OKTAPEHTT Technologies, Inc.KGX2026-07-31
06979191883690EQUATEWAL-MART STORES, INC.KGX2026-07-31
06979191883706EQUATEWAL-MART STORES, INC.KGX2026-07-31
06979191883713EQUATEWAL-MART STORES, INC.KGX2026-07-31
06979191883720EquateWAL-MART STORES, INC.KGX2026-07-31
06980297490019HuixiangJiangsu Huixiang Intelligent Technology Co., LtdKGX2026-07-31
20618125192339AquaGuardTIDI PRODUCTS, LLCKGX2026-07-28
20618125192384AquaGuardTIDI PRODUCTS, LLCKGX2026-07-28
20618125192391AquaGuardTIDI PRODUCTS, LLCKGX2026-07-28
00850086064003BRIJ-SEALBRIJ Medical, Inc.KGX2026-07-17