FDA.report

CARDINAL HEALTH

Primary DI
50195594772145
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
26-0798A
Catalog number
26-0798A
Device description
MANOMETER KIT
Published
2022-09-08
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
OFECentral venous blood pressure kit

Product Code Classifications

CodeDeviceSpecialtyClass
OFECentral Venous Blood Pressure KitCardiovascular2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
50195594772145PackageGS110In Commercial Distribution
10195594772147PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
5019559477214550195594772145
1019559477214710195594772147

GMDN Terms

TermDefinition
Cardiothoracic surgical procedure kit, non-medicated, single-useA collection of various sterile cardiothoracic surgical instruments, dressings, and materials intended to be used to assist a range of cardiothoracic surgical procedures; it does not contain pharmaceuticals. The kit is intended only for use during cardiothoracic surgery but is not dedicated to a specific type of cardiothoracic surgical procedure. 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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