FDA.reportPublic FDA data

GLOBAL HEALTHCARE

Primary DI
00872237005109
Brand
GLOBAL HEALTHCARE
Company
GHC HEALTHCARE, INC.
Model
60-T165
Device description
PRE-CONNECTED FOLEY CATHETER TRAY. CONTENTS: SILICONE COATED LATEX FOLEY CATHETER 16FR, 5CC. DRAINAGE BAG 2000CC, SYRINGE 10CC PRE-FILLED W/ STERILE WATER, COTTON BALLS (6), VINYL GLOVES (2), DRAPE, FENESTRATED DRAPE, CATHETER LUBRICATING JELLY, POVIDONE-IODINE SOLUTION, SPECIMEN CONTAINER 2oz, PATIENT LABEL, FORCEPS, WRAP.
Published
2017-02-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FCMTray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FCMTray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)Gastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
40872237005107PackageGS110In Commercial Distribution
00872237005109PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
4087223700510740872237005107
00872237005109008722370051098722370051090872237005109

GMDN Terms#

Term, Definition table
TermDefinition
Indwelling urethral catheterization kit, adultA collection of devices that includes an indwelling urethral catheter which incorporates a balloon (commonly known as a Foley catheter), and devices associated with catheter introduction/function (e.g., gloves, lubricating gel, drapes), intended for urinary drainage from the bladder of an adult or paediatric patient. The catheter will be applied by trained staff and may be coated with an antibiotic to help prevent catheter-associated urinary tract infection (CAUTI). This is a single-use device.

Regulatory Flags#

DUNS number
884718776
Device count
1
Kit
true
Combination product
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00872237001804GLOBAL HEALTHCARE60-T022023-03-16
40872237001802GLOBAL HEALTHCARE60-T022023-03-16
00872237008568GLOBAL HEALTHCARE60-TN14012017-02-10
00872237001088GLOBAL HEALTHCARE63-45302017-02-10
00872237001095GLOBAL HEALTHCARE63-45312017-02-10
00872237001101GLOBAL HEALTHCARE63-45322017-02-10
00872237004256GLOBAL HEALTHCAREUB-LE6002016-09-12
00872237005192GLOBAL HEALTHCARE81-0012016-09-12
00872237005208GLOBAL HEALTHCARE81-0022016-09-12
00872237008674GLOBAL HEALTHCARE81-003A2016-09-12
00872237008681GLOBAL HEALTHCARE81-004A2016-09-12
00872237008698GLOBAL HEALTHCARE81-005A2016-09-12
00872237008711GLOBAL HEALTHCARE81-007A2016-09-12
00872237009114GLOBAL HEALTHCARE07-21M 2020-08-04
00872237009121GLOBAL HEALTHCARE07-21L2020-08-04
00872237009138GLOBAL HEALTHCARE07-21XL2020-08-04
00872237009145GLOBAL HEALTHCARE07-21XXL2020-08-04
00872237004263GLOBAL HEALTHCAREUB-PC2016-09-12
00872237004270GLOBAL HEALTHCAREUB-RC2016-09-12
00872237004751GLOBAL HEALTHCAREUB-P2016-09-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10192253068566DoverCardinal Health 200, LLCFCM2026-01-16
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10192253068665DoverCardinal Health 200, LLCFCM2026-01-16
10192253068702DoverCardinal Health 200, LLCFCM2026-01-16
10192253067958DoverCardinal Health 200, LLCFCM2026-01-15
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10192253070859DoverCardinal Health 200, LLCFCM2026-01-15
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10192253028935DoverCardinal Health 200, LLCFCM2025-09-16
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10704411019602AMSure® Foley Catheter TrayAMSINO INTERNATIONAL, INC.FCM2025-07-01
10704411019619AMSure® Foley Catheter TrayAMSINO INTERNATIONAL, INC.FCM2025-07-01