FDA.reportPublic FDA data

GLOBAL HEALTHCARE

Primary DI
40872237008177
Brand
GLOBAL HEALTHCARE
Company
Global Healthcare
Model
60-T1852
Device description
PRE-CONNECTED FOLEY CATHETER TRAY. CONTENTS: SILICONE COATED LATEX FOLEY CATHETER 18FR, 5CC. DRAINAGE BAG 2000CC, SYRINGE 10CC PRE-FILLED W/ STERILE WATER, VINYL GLOVES (2), PVP SWABSTICKS (3), DRAPE, FENESTRATED DRAPE, CATHETER LUBRICATING JELLY, SPECIMEN CONTAINER 2oz, PATIENT LABEL, 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
OTC
false
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
40872237008177PackageGS110In Commercial Distribution
00872237008179PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
4087223700817740872237008177
00872237008179008722370081798722370081790872237008179

GMDN Terms#

Term, Definition table
TermDefinition
Indwelling urethral catheterization kitA collection of sterile devices that includes an indwelling urethral catheter (commonly known as a Foley catheter), gloves, lubricating gel, and other related accessories intended for the drainage of urine from the bladder. The catheter has an inflatable balloon at the distal tip for retention in the urinary bladder after its insertion through the urethra, where it usually functions as an indwelling therapeutic device for urinary incontinence or as a means to void for non-ambulatory patients. The catheter will be applied by trained staff and may or may not be coated with an antibiotic to help prevent catheter-associated urinary tract infection (CAUTI). This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
884718776
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
true
Lot or batch
true
Serial number
false
Manufacturing date on label
true
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
40872237000218GLOBAL HEALTHCARE04-EL2017-02-10
40872237000249GLOBAL HEALTHCARE04-TO2017-02-10
40872237002496GLOBAL HEALTHCARE61-0652019-06-05
40872237002502GLOBAL HEALTHCARE61-0702019-06-05
40872237002519GLOBAL HEALTHCARE61-0752019-06-05
40872237002526GLOBAL HEALTHCARE61-0802019-06-05
40872237002403GLOBAL HEALTHCARE61-0202016-09-23
40872237002410GLOBAL HEALTHCARE61-0252016-09-23
40872237002427GLOBAL HEALTHCARE61-0302016-09-23
40872237002434GLOBAL HEALTHCARE61-0352016-09-23
40872237002441GLOBAL HEALTHCARE61-0402016-09-23
40872237002458GLOBAL HEALTHCARE61-0452016-09-23
40872237002465GLOBAL HEALTHCARE61-0502016-09-23
40872237002472GLOBAL HEALTHCARE61-0552016-09-23
40872237002489GLOBAL HEALTHCARE61-0602016-09-23
40872237002533GLOBAL HEALTHCARE61-1502016-09-23
40872237002540GLOBAL HEALTHCARE61-1552016-09-23
40872237002557GLOBAL HEALTHCARE61-1602016-09-23
40872237002564GLOBAL HEALTHCARE61-1652016-09-23
40872237002571GLOBAL HEALTHCARE61-1702016-09-23

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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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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10704411019619AMSure® Foley Catheter TrayAMSINO INTERNATIONAL, INC.FCM2025-07-01