FDA.reportPublic FDA data

McKesson

Primary DI
10612479242613
Brand
McKesson
Company
MCKESSON MEDICAL-SURGICAL INC.
Model
16- MH1618C
Device description
Intermittent Catheter HYDROPHILIC STERILE WATER PACKET COUDE TIP MALE/UNIVERSAL PVC STERILE 16 Inch 18 Fr
Published
2019-01-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
GBMCatheter, Urethral

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GBMCatheter, UrethralGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K111405000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K111405000BEVER UNOCATED / COATED, PAEDIATRIC / MALE / FEMALE NELATON-TIP / TIEMANN-TIP INTERMITTENT CATHETER,Hangzhou Bever Medical Devices Co., Ltd.2012-02-13GBM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20612479242627PackageGS130In Commercial Distribution
40612479242638PackageGS110In Commercial Distribution
10612479242613PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2061247924262720612479242627
4061247924263840612479242638
1061247924261310612479242613

GMDN Terms#

Term, Definition table
TermDefinition
Intermittent urethral drainage catheter, non-antimicrobial, reusableA flexible or rigid tube designed to be repeatedly inserted through the urethra, typically by the user (i.e., self-applied), to the urinary bladder to provide short-term, episodic urine drainage (removed after each void), typically for an individual who is physiologically incapable of voiding. Because of the potential frequency of catheterization, the device is typically pre-lubricated or coated with/made of materials that facilitate easy insertion and removal [e.g., polytetrafluoroethylene (PTFT) - Teflon, or glass]; it does not include an antimicrobial agent(s). The device may be male or female dedicated. This is a reusable device.

Regulatory Flags#

DUNS number
023904428
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10612479235592McKesson16-18502020-06-10
10612479235608McKesson16-18522020-06-10
10612479258317McKesson16-18602020-06-25
10612479258348McKesson16-18622020-06-25
20612479203710McKesson326302020-07-21
10612479169064McKesson101-87032016-12-09
10612479169125McKesson101-87102016-12-09
10612479284002McKesson16-6219-B2026-08-03
10612479284026McKesson16-6218-B2026-08-03
10612479284040McKesson16-6220-B2026-08-03
10612479284064McKesson16-6221-B2026-08-03
10612479284101McKesson16-6379-B2026-08-03
10612479284125McKesson16-6216-B2026-08-03
00612479151291McKesson16-DEN-12026-07-09
00612479274648McKesson48392025-01-17
20612479285723McKessonGCCOV-502a-MB2026-06-18
20612479285747McKessonCCOVAg-PNMB2026-06-18
00612479271050McKesson16-L2NWT6Y-XL2024-04-17
20612479282852McKessonM-1669H2026-05-26
20612479282883McKessonM-662G2026-05-26

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Primary DI, Brand, Company table
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