FDA.report

CARDINAL HEALTH

Primary DI
50195594515988
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SMARPOEHF1
Catalog number
SMARPOEHF1
Device description
OB EMERGENCY PACK
Published
2022-01-23
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
OKUEmergency obstetrical kit

Product Code Classifications

CodeDeviceSpecialtyClass
OKUEmergency Obstetrical KitObstetrics/Gynecology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
50195594515988PackageGS14In Commercial Distribution
10195594515980PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
5019559451598850195594515988
1019559451598010195594515980

GMDN Terms

TermDefinition
Obstetrical/gynaecological surgical procedure kit, non-medicated, single-useA collection of various sterile surgical instruments, dressings/drapes, and materials intended to be used during obstetrical/gynaecological surgery. The kit may be referred to as a procedure pack and is typically comprised of devices that individually are not dedicated to a specific type of obstetrical/gynaecological surgical procedure, but are often supplied together to perform a specific type of obstetrical/gynaecological procedure; it does not contain pharmaceuticals. This is a single-use device.

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

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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