FDA.reportPublic FDA data

GLOBAL HEALTHCARE

Primary DI
40872237005244
Brand
GLOBAL HEALTHCARE
Company
Global Healthcare
Model
60-T01
Device description
UNIVERSAL CATHETERIZATION TRAY. CONTENTS: 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
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
40872237005244PackageGS110In Commercial Distribution
00872237005246PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
4087223700524440872237005244
00872237005246008722370052468722370052460872237005246

GMDN Terms#

Term, Definition table
TermDefinition
Urethral catheterization support kit, urinary drainageA collection of sterile, 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.

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
false
No natural rubber latex
true
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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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