CARDINAL HEALTH CHBUTK3

GUDID 50885380169432

Urine Transfer Kit, Contains Urine Transfer Device and 9mL UA Conical Tube No Additive

Aero-Med, Ltd.

Urine specimen collection kit IVD Urine specimen collection kit IVD Urine specimen collection kit IVD Urine specimen collection kit IVD
Primary Device ID50885380169432
NIH Device Record Key25292b9c-6660-4d64-843b-97a8ff0f9c13
Commercial Distribution StatusIn Commercial Distribution
Brand NameCARDINAL HEALTH
Version Model NumberCHBUTK3
Catalog NumberCHBUTK3
Company DUNS194550042
Company NameAero-Med, Ltd.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Operating and Storage Conditions

Storage Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS110885380169434 [Primary]
GS110885380169434 [Primary]
GS110885380169434 [Primary]
GS110885380169434 [Primary]
GS150885380169432 [Package]
Contains: 10885380169434
Package: CASE [100 Units]
In Commercial Distribution
GS150885380169432 [Package]
Contains: 10885380169434
Package: CASE [100 Units]
In Commercial Distribution
GS150885380169432 [Package]
Contains: 10885380169434
Package: CASE [100 Units]
In Commercial Distribution
GS150885380169432 [Package]
Contains: 10885380169434
Package: CASE [100 Units]
In Commercial Distribution

FDA Product Code

OIBBlood and urine collection kit (excludes HIV testing)
OIBBlood and urine collection kit (excludes HIV testing)
OIBBlood and urine collection kit (excludes HIV testing)
OIBBlood and urine collection kit (excludes HIV testing)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-05-21
Device Publish Date2020-05-13

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50192253021972Blood Culture Collection Kit, Washington Hospital Center MedStar Only
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50885380169432Urine Transfer Kit, Contains Urine Transfer Device and 9mL UA Conical Tube No Additive
50885380169425Urine Transfer Kit, Contains Urine Transfer Device and 10mL Round Bottom Tube No Additive
50885380169418Urine Transfer Kit, Contains Urine Transfer Device and CCM Tube

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