FDA.report

CARDINAL HEALTH

Primary DI
50195594396266
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
30A2808D
Catalog number
30A2808D
Device description
SAFE CENT 6FRX5 CATH MERIT KIT
Published
2022-02-22
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
PYCParacentesis tray

Product Code Classifications

CodeDeviceSpecialtyClass
PYCParacentesis TrayGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
50195594396266PackageGS116In Commercial Distribution
10195594396268PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
5019559439626650195594396266
1019559439626810195594396268

GMDN Terms

TermDefinition
General surgical procedure kit, medicatedA general-purpose collection of various surgical instruments, dressings, and materials, including a pharmaceutical component, intended to be used to assist a range of surgical procedures across multiple clinical specialities. 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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