FDA.reportPublic FDA data

ZONAS® by Actimove®

Primary DI
04042809649796
Brand
ZONAS® by Actimove®
Company
BSN MEDICAL, INC.
Model
65001-04
Catalog number
65001-04
Device description
ZONAS ATHLETIC TAPE 1IN X 10YDS 12
Published
2025-09-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Contact Domains#

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
04042809649796PackageGS112In Commercial Distribution
04042809649277PrimaryGS10
04042809823264Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04042809649796040428096497964042809649796
04042809649277040428096492774042809649277
04042809823264040428098232644042809823264

GMDN Terms#

Term, Definition table
TermDefinition
Pressure bandage, Hevea-latex, single-useA strip or roll made of fabric with Hevea natural rubber latex (NRL) intended to be applied to and compress a local area of the body for various preventative/therapeutic applications (e.g., to stop bleeding, prevent oedema, provide support for varicose veins). The latex component is intended to create a bandage that clings to itself more than to skin so that compression can be maintained over longer periods. It is intended for use in the home or healthcare facility. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length914.4Centimeter
Width2.54Centimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep dry, Keep away from sunlight

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)537-1063HMS.ORDERS@ESSITY.COM

Regulatory Flags#

DUNS number
026301221
Device count
12
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
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
true
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00035664600266JOBST Custom Seamed75074-0075074-002026-05-11
00035664600273JOBST Custom Seamed75074-0175074-012026-05-11
00035664600860JOBST Custom Seamed75065-0075065-002026-05-11
00035664600891JOBST Custom Seamed75066-0075066-002026-05-11
00035664601089JOBST Custom Seamed75067-0075067-002026-05-11
00035664601348JOBST Custom Seamed75064-0075064-002026-05-11
00035664601355JOBST Custom Seamed75064-0175064-012026-05-11
00035664601423JOBST Custom Seamed75071-0075071-002026-05-11
00035664601430JOBST Custom Seamed75071-0175071-012026-05-11
00035664601447JOBST Custom Seamed75071-0275071-022026-05-11
00035664601454JOBST Custom Seamed75072-0075072-002026-05-11
00035664601461JOBST Custom Seamed75071-0675071-062026-05-11
00035664601478JOBST Custom Seamed75071-0775071-072026-05-11
00035664601508JOBST Custom Seamed75071-0375071-032026-05-11
00035664601515JOBST Custom Seamed75071-0475071-042026-05-11
00035664601522JOBST Custom Seamed75071-0575071-052026-05-11
04042809633061JOBST Sport752896175289612018-06-30
04042809633146JOBST Sport752906175290612018-06-30
04042809649277ZONAS® by Actimove®65001-0465001-042025-09-02
04042809818574ZONAS® by Actimove®65001-0165001-012025-09-02

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