FDA.report

McKesson

Primary DI
40612479129298
Brand
McKesson
Company
MCKESSON MEDICAL-SURGICAL INC.
Model
16-9526
Device description
Specimen Container 4 oz with Lid
Published
2020-07-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
FMHContainer, Specimen, Sterile

Product Code Classifications

CodeDeviceSpecialtyClass
FMHContainer, Specimen, SterilePathology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
40612479129298PackageGS1100In Commercial Distribution
10612479140216PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
4061247912929840612479129298
1061247914021610612479140216

GMDN Terms

TermDefinition
Urine transfer IVD, sterileA sterile plastic adaptor or dedicated transfer device, intended to be used to assist with the aseptic transfer of a urine specimen from the primary collection container to an evacuated urine specimen container for subsequent culture, analysis, and/or other investigation. This is a single-use device.

Sterilization Methods

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
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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