FDA.report

McKesson

Primary DI
00612479249097
Brand
McKesson
Company
MCKESSON MEDICAL-SURGICAL INC.
Model
16-UCC4
Device description
COLLECTION KIT, URINE CUP 4oz
Published
2019-09-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
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
00612479249097PackageGS1200In Commercial Distribution
00612479249080PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00612479249097006124792490976124792490970612479249097
00612479249080006124792490806124792490800612479249080

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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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20612479283392McKessonM-J496G2026-05-26
20612479283408McKessonM-J493G2026-05-26
20612479283415McKessonM-J546G2026-05-26

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