FDA.reportPublic FDA data

Closed Circuit Foley Catheter Tray

Primary DI
00100121850291
Brand
Closed Circuit Foley Catheter Tray
Company
Medical Shipment, LLC
Model
8502
Published
2017-02-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
OHRCatheter Care Tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OHRCatheter Care TrayGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00100121850291PrimaryGS10
00100121850284Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00100121850291001001218502911001218502910100121850291
00100121850284001001218502841001218502840100121850284

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
962616673
Device count
10
Kit
true
Lot or batch
true
Expiration date on label
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850056286084Medical Shipment100042025-10-01
00850056286008Medical Shipment100032023-08-28
00850056286022Medical Shipment100052023-08-28
00850056286046Medical Shipment120012023-08-28
00850056286060Medical Shipment130012023-08-28
00100121850192Closed Circuit Foley Catheter Tray85012017-02-01
00100121851199Closed Circuit Foley Catheter Tray85112017-02-01

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