FDA.report

McKesson

Primary DI
00612479247994
Brand
McKesson
Company
MCKESSON MEDICAL-SURGICAL INC.
Model
18-3400LFC-10PK
Device description
Catheter, Foley Grip-Lok Anchor Device LG STR (10/PK))
Published
2020-05-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
EYJHolder, Ureteral Catheter

Product Code Classifications

CodeDeviceSpecialtyClass
EYJHolder, Ureteral CatheterGastroenterology, Urology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00612479247987PrimaryGS10
00612479247994Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00612479247987006124792479876124792479870612479247987
00612479247994006124792479946124792479940612479247994

GMDN Terms

TermDefinition
Indwelling urethral drainage catheter, non-antimicrobialA flexible tube with an inflatable balloon at its distal tip intended to be inserted through the urethra and retained in the urinary bladder, or prostatic bed, to function as an indwelling therapeutic device for urinary drainage; it might be designed to also allow for infusion of fluids (irrigation). It may have a bent tip (coude) to facilitate insertion, and some types may be provided with a guidewire to facilitate difficult insertion (e.g., in cases of enlarged prostate); it does not include an antimicrobial agent(s). Most types are commonly known as a Foley catheter; it is intended to be introduced by a healthcare professional. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
023904428
Device count
10
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
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 DIBrandModelCatalogPublished
20612479282852McKessonM-1669H2026-05-26
20612479282883McKessonM-662G2026-05-26
20612479282890McKessonM-1667G2026-05-26
20612479282906McKessonM-1667H2026-05-26
20612479282913McKessonM-698G2026-05-26
20612479282920McKessonM-1666G2026-05-26
20612479282937McKessonM-1698G2026-05-26
20612479282944McKessonM-663G2026-05-26
20612479283019McKessonM-699G2026-05-26
20612479283194McKessonM-8699G2026-05-26
20612479283200McKessonM-8682G2026-05-26
20612479283217McKessonM-8698G2026-05-26
20612479283224McKessonM-8686G2026-05-26
20612479283231McKessonM-8697G2026-05-26
20612479283248McKessonM-8695G2026-05-26
20612479283255McKessonM-685G2026-05-26
20612479283385McKessonM-J494G2026-05-26
20612479283392McKessonM-J496G2026-05-26
20612479283408McKessonM-J493G2026-05-26
20612479283415McKessonM-J546G2026-05-26

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00610570176526CATH-MATE II CATHETER STRAPBird & Cronin, LLCEYJ2022-08-30
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