FDA.report

CARDINAL HEALTH

Primary DI
20885380163545
Brand
CARDINAL HEALTH
Company
CARDINAL HEALTH 200, LLC
Model
C8552-12S
Catalog number
C8552-12S
Device description
Collection and Transport Swab Microorganism Collection and Transport System
Published
2018-12-18
Public version status
Update
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
LIODevice, specimen collection

Product Code Classifications

CodeDeviceSpecialtyClass
LIODevice, Specimen CollectionMicrobiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20885380163545PackageGS150In Commercial Distribution
50885380163546PackageGS110In Commercial Distribution
10885380163548PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
2088538016354520885380163545
5088538016354650885380163546
1088538016354810885380163548

GMDN Terms

TermDefinition
General specimen transport medium collection kit, sterileA collection of sterile devices intended to be used for the collection, preservation, and transport of any type of clinical specimen (e.g., faeces, sputum, mucous, wound exudate, vaginal secretion) collected from any body part [e.g., natural orifice, skin (i.e., it is not dedicated to a body region)] for investigation by in vitro diagnostic procedures [e.g., nucleic acid technique (NAT), microbiological culture, histopathology]. It includes a specimen collection tool(s) [e.g., swab, brush, spatula], and a covered plastic receptacle containing a transport medium (e.g., cell or nucleic acid preservation solution, microbiological medium). This is a single-use device.

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature4 Degrees Celsius25 Degrees Celsius

Sterilization Methods

Method
Radiation Sterilization

Regulatory Flags

DUNS number
112164780
Device count
1
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
true

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