FDA.report

CARDINAL HEALTH

Primary DI
10885380171109
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
CAX1230LA
Catalog number
CAX1230LA
Device description
CAX FRZ PLASMA 12cf 120v/60Hz
Published
2020-06-21
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
JRMFREEZER

Product Code Classifications

CodeDeviceSpecialtyClass
JRMFreezerClinical Chemistry1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10885380171109PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1088538017110910885380171109

GMDN Terms

TermDefinition
Blood/tissue storage/culture containerA durable, sterile plastic container with ports, or glass bottle, intended for the storage and/or culture of tissue, cells, blood or blood components (e.g., peripheral blood stem cells) typically for subsequent therapeutic applications. The device provides a suitable closed environment to reduce the risk of contamination and, if applicable, for cell growth/viability during storage that may or may not involve freezing. A device intended for cryopreservation is typically designed for long-term storage in a freezing system. A device intended for culture is typically gas permeable and may have an inner surface that enables adherence. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
961027315
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
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

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