FDA.reportPublic FDA data

CathGuard

Primary DI
10858293006189
Brand
CathGuard
Company
REPROCESSING PRODUCTS CORPORATION
Model
7001-3920
Device description
Patient Catheter Protective Pocket
Published
2019-08-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
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
10858293006189PackageGS1100In Commercial Distribution
00858293006182PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085829300618910858293006189
00858293006182008582930061828582930061820858293006182

GMDN Terms#

Term, Definition table
TermDefinition
Non-adhesive device retention bandageA piece or roll of material intended to be wrapped around a part of the body to secure a device (e.g., skin dressing, catheter, cannula) to the patient, without adhering to or compressing the body. It may be made from a variety or combination of materials, including cotton, viscose, and plastic (e.g., polyamide), and some types are cohesive (i.e., the bandage adheres to itself but not to other surfaces); it is used in various clinical specialties (e.g., dermatology, general/plastic surgery). This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
796083392
Device count
1
DM exempt
true
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
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
00858293006939Peracidin0818942026-07-24
00858293006946Peracidin0818962026-07-24
00858293006328EZ-ChekK100-0101BK100-0101B2017-03-07
00858293006915Accu-ReadBP00-22012025-04-02
00858293006120Micro-XK100-0105K100-01052017-03-07
00858293006922Micro-XMX-32122023-02-20
00858293006458Luer Fitting FemaleBF00-00102019-08-30
00858293006465Luer Fitting MaleBF00-00112019-08-30
00858293006496Black Tubing, NaturalBT00-01002019-08-30
00858293006502Black Tubing, PVCBT00-01032019-08-30
00858293006908Spiral Coil Tubing, Trans BluePU532-8TD0PU532-8WT02021-05-17
00858293006373E-Z Chek5116AK100-01172017-03-07
00858293006380EZ-Chek5100AK100-0101B2017-03-07
00858293006885Spiral Coil Tubing, Clear1W-013-102021-05-17
00858293006892Spiral Coil Tubing, Trans RedPU532-8WD02021-05-17
00858293006861Sani-lok Blood Port Barrier Adaptor7000-10502021-05-13
00858293006878Sani-lok Blood Port Barrier Adaptor7000-10502021-05-13
00858293006700Spiral Tubing, Trans Red1W-013-252019-08-30
00858293006717Spirial Tubing, Trans Blue1W-013-272019-08-30
00858293006724Spiral Coil Tubing Clear1W-025-102019-08-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
06979191883744OKTAPEHTT Technologies, Inc.KGX2026-09-02
06979191883751OKTAPEHTT Technologies, Inc.KGX2026-09-02
06979191883768OKTAPEHTT Technologies, Inc.KGX2026-09-02
06979191883775OKTAPEHTT Technologies, Inc.KGX2026-09-02
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