FDA.reportPublic FDA data

GLOBAL HEALTHCARE

Primary DI
40872237008566
Brand
GLOBAL HEALTHCARE
Company
Global Healthcare
Model
60-TN1401
Device description
URETHRAL CATHETER TRAY. CONTENTS: URETHRAL PVC CATHETER 14FR., VINYL GLOVES (2), PVP SWABSTICKS (3), DRAPE, FENESTRATED DRAPE, CATHETER LUBRICATING JELLY, SPECIMEN CONTAINER 2oz, OUTER BASIN TRAY, 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
40872237008566PackageGS110In Commercial Distribution
00872237008568PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
4087223700856640872237008566
00872237008568008722370085688722370085680872237008568

GMDN Terms#

Term, Definition table
TermDefinition
Intermittent urethral catheterization kit, sterileA collection of sterile devices that includes a urological catheter (with or without a urine drainage bag), a cap, and other related accessories intended for self-urinary catheterization. The catheter may be repeatedly inserted through the urethra by the user to provide short-term, episodic urine drainage. Because of the potential frequency of catheterization, the catheter will typically be pre-lubricated or coated with/made of materials that facilitate easy insertion and removal [e.g., polytetrafluoroethylene (PTFT) commonly known as Teflon, or glass], and possibly coated with an antibiotic to help prevent infection of the urinary tract. This is a reusable 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
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