FDA.report

CARDINAL HEALTH

Primary DI
50195594035110
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
29-0083C
Catalog number
29-0083C
Device description
AMNIOCENTESIS TRAY
Published
2021-04-27
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
HIOSampler, amniotic fluid (amniocentesis tray)

Product Code Classifications

CodeDeviceSpecialtyClass
HIOSampler, Amniotic Fluid (Amniocentesis Tray)Obstetrics/Gynecology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
50195594035110PackageGS115In Commercial Distribution
10195594035112PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
5019559403511050195594035110
1019559403511210195594035112

GMDN Terms

TermDefinition
Amniocentesis kit, medicated, single-useA collection of sterile devices designed to aspirate and contain a sample of amniotic fluid from the amniotic sac, via a transabdominal approach, for analysis. Components typically include a needle with stylet and syringe, specimen containers/medium, drapes, dressings, and pharmaceuticals. The device is typically used at 16-18 weeks gestation for antepartum diagnosis of certain congenital abnormalities (e.g., Down syndrome, spina bifida), or anytime after 24-weeks gestation to assess foetal maturity. 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
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
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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