FDA.report

McKesson

Primary DI
10612479239644
Brand
McKesson
Company
MCKESSON MEDICAL-SURGICAL INC.
Model
25-460
Device description
Calculi Strainers
Published
2020-04-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
KNXCollector, Urine, (And Accessories) For Indwelling Catheter

Product Code Classifications

CodeDeviceSpecialtyClass
KNXCollector, Urine, (And Accessories) For Indwelling CatheterGastroenterology, Urology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
40612479140125PrimaryGS10
10612479239644Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
4061247914012540612479140125
1061247923964410612479239644

GMDN Terms

TermDefinition
Urine strainerA device designed to collect stones (calculi) from urine during normal micturition (urination). It is typically designed as a sieve-like container with handles for holding and emptying, and is typically mounted into a funnel/holder system that may be attached to a dedicated treatment table or chair. The collected stones are typically sent to the clinical laboratory for examination and composition determination to facilitate patient diagnosis and/or therapy. This is a reusable device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
023904428
Device count
100
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
false
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
00612479282179McKesson16-4839-22026-03-17
00612479124448McKesson16-71312026-03-11
00612479124455McKesson16-71322026-03-11
00612479124462McKesson16-71332026-03-11
00612479135468McKesson16-71352026-03-11
00612479135512McKesson16-71362026-03-11
00612479160651McKesson70-101PMCK2026-03-11
00612479160668McKesson70-105PMCK2026-03-11
00612479160675McKesson70-109PMCK2026-03-11
00612479185388McKesson70-1121MCK2026-03-11
00612479185395McKesson70-1122MCK2026-03-11
40612479280920McKesson16-1000-PMBL2026-02-26
40612479262162McKesson18-3300M2026-02-23
10612479275932McKesson91-31052026-02-20
10612479281575McKesson181-342252026-02-06
10612479281582McKesson181-342252026-02-06
00612479278356McKesson16-61442026-01-26
00612479278370McKesson16-61482026-01-26
00612479278387McKesson16-61682026-01-26
00612479278431McKesson16-618102026-01-26

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16974500612586Disposable Urinary Drainage BagGCMEDICA ENTERPRISE LTD.(WUXI)KNX2025-08-07
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50192253028568DoverCardinal Health 200, LLCKNX2024-12-20
50192253028520DoverCardinal Health 200, LLCKNX2024-12-20
50192253028537DoverCardinal Health 200, LLCKNX2024-12-20
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50192253028469DoverCardinal Health 200, LLCKNX2024-12-20
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50192253028551DoverCardinal Health 200, LLCKNX2024-12-20
50192253027936DoverCardinal Health 200, LLCKNX2024-11-04
50192253028285DoverCardinal Health 200, LLCKNX2024-11-04
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50192253028193DoverCardinal Health 200, LLCKNX2024-10-14
50192253028209DoverCardinal Health 200, LLCKNX2024-10-14