FDA.reportPublic FDA data

McKesson

Primary DI
00612479247970
Brand
McKesson
Company
MCKESSON MEDICAL-SURGICAL INC.
Model
18-3400LFC
Device description
Catheter, Foley Grip-Lok Anchor Device LG STR (100/BX)
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

Product Codes#

Code, Name table
CodeName
EYJHolder, Ureteral Catheter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EYJHolder, Ureteral CatheterGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00612479247970PackageGS1100In Commercial Distribution
00612479262171PackageGS110In Commercial Distribution
00612479247963PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00612479247970006124792479706124792479700612479247970
00612479262171006124792621716124792621710612479262171
00612479247963006124792479636124792479630612479247963

GMDN Terms#

Term, Definition table
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 table
Method

Regulatory Flags#

DUNS number
023904428
Device count
1
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 DI, Brand, Model table
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10850067913006TruLockHR PHARMACEUTICALS INC.EYJ2026-03-06
10850067913013TruLockHR PHARMACEUTICALS INC.EYJ2026-03-06
00612479281196McKessonMCKESSON MEDICAL-SURGICAL INC.EYJ2026-01-20
00612479280717McKessonMCKESSON MEDICAL-SURGICAL INC.EYJ2026-01-20
00612479281219McKessonMCKESSON MEDICAL-SURGICAL INC.EYJ2026-01-20
00612479281233McKessonMCKESSON MEDICAL-SURGICAL INC.EYJ2026-01-20
05430004283539FlexGRIPBedalEYJ2025-12-03
05430004283799FlexGRIPBedalEYJ2025-12-03
05430003674291FlexGRIPBedalEYJ2025-12-01
06009900639604Another HandWISMED PL SP Z O OEYJ2025-03-17
10850058254330TruLockHR PHARMACEUTICALS INC.EYJ2025-03-03
10850058254361TruLockHR PHARMACEUTICALS INC.EYJ2025-03-03
50850058254376TruLockHR PHARMACEUTICALS INC.EYJ2025-03-03
10653160386360CenturionCENTURION MEDICAL PRODUCTS CORPORATIONEYJ2025-02-14
30618125134718Grip-LokPOSEY PRODUCTS, LLCEYJ2024-12-02
00618125192175Grip-LokTIDI PRODUCTS, LLCEYJ2024-12-02
20193489102724MEDLINEMEDLINE INDUSTRIES, INC.EYJ2024-09-19
10885632417115HalyardOWENS & MINOR DISTRIBUTION, INC.EYJ2024-07-29
G0960R867530959LineRising Eagle Medical LLCEYJ2024-01-30
80618125134782Grip-LokTIDI PRODUCTS, LLCEYJ2023-06-29
10048329000193CATH-SECURE LOCKM.C. JOHNSON CO., INC.EYJ2023-06-08
20193489102717MedlineMEDLINE INDUSTRIES, INC.EYJ2022-11-10
10618125135162Grip-LokTIDI PRODUCTS, LLCEYJ2022-10-18
10618125134776Grip-LokTIDI PRODUCTS, LLCEYJ2022-10-13
10618125134899Grip-LokTIDI PRODUCTS, LLCEYJ2022-10-13
00618125134786Grip-LokTIDI PRODUCTS, LLCEYJ2022-10-13
00610570176519CHAS CATH-MATE STRAPBird & Cronin, LLCEYJ2022-08-30
00610570176526CATH-MATE II CATHETER STRAPBird & Cronin, LLCEYJ2022-08-30
00610570176786CHAS II CATH-MATE STRAPBird & Cronin, LLCEYJ2022-08-30
00610570187379CATH-MATE II X-LONG STRAP 28"Bird & Cronin, LLCEYJ2022-08-30