FDA.reportPublic FDA data

GLOBAL HEALTHCARE

Primary DI
00872237001804
Brand
GLOBAL HEALTHCARE
Company
GHC HEALTHCARE, INC.
Model
60-T02
Device description
UNIVERSAL CATHETERIZATION TRAY.CONTENTS: DRAINAGE BAG 2000 CC, SYRINGE 10 CC PRE-FILLED WITH STERILE WATER, VINYL GLOVES (1 PAIR), DRAPE, FENESTRATED DRAPE, CATHETER LUBRICATING JELLY, SPECIMEN CONTAINER 2oz, PATIENT LABEL, WRAP, PVP SWAB STICKS (3).
Published
2023-03-16
Public version status
New
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
40872237001802PackageGS110In Commercial Distribution
00872237001804PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
4087223700180240872237001802
00872237001804008722370018048722370018040872237001804

GMDN Terms#

Term, Definition table
TermDefinition
Urethral catheterization support kit, urinary drainageA collection of non-surgically invasive devices intended to assist a healthcare professional to insert a urethral catheter (not included) into the urinary bladder, typically for drainage of urine; some types may also be intended for catheter removal. It typically includes forceps, dressings, gloves, and drapes; it does not include pharmaceuticals. This is a single-use device.

Regulatory Flags#

DUNS number
884718776
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00872237005109GLOBAL HEALTHCARE60-T1652017-02-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
14026704945990RUSCHTELEFLEX INCORPORATEDFCM2026-05-12
10192253069549DoverCardinal Health 200, LLCFCM2026-01-20
10192253068535DoverCardinal Health 200, LLCFCM2026-01-16
10192253068542DoverCardinal Health 200, LLCFCM2026-01-16
10192253068559DoverCardinal Health 200, LLCFCM2026-01-16
10192253068566DoverCardinal Health 200, LLCFCM2026-01-16
10192253068573DoverCardinal Health 200, LLCFCM2026-01-16
10192253068580DoverCardinal Health 200, LLCFCM2026-01-16
10192253068597DoverCardinal Health 200, LLCFCM2026-01-16
10192253068610DoverCardinal Health 200, LLCFCM2026-01-16
10192253068665DoverCardinal Health 200, LLCFCM2026-01-16
10192253068702DoverCardinal Health 200, LLCFCM2026-01-16
10192253067958DoverCardinal Health 200, LLCFCM2026-01-15
10192253067996DoverCardinal Health 200, LLCFCM2026-01-15
10192253068009DoverCardinal Health 200, LLCFCM2026-01-15
10192253070859DoverCardinal Health 200, LLCFCM2026-01-15
10192253027754DoverCardinal Health 200, LLCFCM2025-12-10
10192253028836DoverCardinal Health 200, LLCFCM2025-12-10
10192253028843DoverCardinal Health 200, LLCFCM2025-12-10
10192253030174DoverCardinal Health 200, LLCFCM2025-10-17
10192253028935DoverCardinal Health 200, LLCFCM2025-09-16
10192253028942DoverCardinal Health 200, LLCFCM2025-09-16
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10704411019558AMSure® Foley Catheter TrayAMSINO INTERNATIONAL, INC.FCM2025-07-01
10704411019565AMSure® Foley Catheter TrayAMSINO INTERNATIONAL, INC.FCM2025-07-01
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10704411019589AMSure® Foley Catheter TrayAMSINO INTERNATIONAL, INC.FCM2025-07-01
10704411019596AMSure® Foley Catheter TrayAMSINO INTERNATIONAL, INC.FCM2025-07-01
10704411019602AMSure® Foley Catheter TrayAMSINO INTERNATIONAL, INC.FCM2025-07-01
10704411019619AMSure® Foley Catheter TrayAMSINO INTERNATIONAL, INC.FCM2025-07-01