FDA.report

Monoject

Primary DI
50192253050996
Brand
Monoject
Company
Cardinal Health 200, LLC
Model
8881301819
Catalog number
8881301819
Device description
Blood Collection Tube
Published
2024-02-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
GIMTubes, vacuum sample, with anticoagulant

Product Code Classifications

CodeDeviceSpecialtyClass
GIMTubes, Vacuum Sample, With AnticoagulantClinical Chemistry2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
50192253050996PackageGS110In Commercial Distribution
20192253050995PrimaryGS10
10192253050998Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
5019225305099650192253050996
2019225305099520192253050995
1019225305099810192253050998

GMDN Terms

TermDefinition
Non-evacuated blood collection tube IVD, no additiveA non-evacuated glass or plastic tube, sealed with a stopper, containing no additive and intended to be used for the collection, and preservation and/or transport, of blood for analysis and/or other investigation. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
961027315
Device count
100
DM exempt
false
Premarket exempt
false
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
false
Sterilization required before use
false

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50198956308006CARDINAL HEALTHSOP21KPSCJSOP21KPSCJ2026-03-24
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50198956322897CARDINAL HEALTHSEN1DNSUNNSEN1DNSUNN2026-03-24
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