FDA.report

CARDINAL HEALTH

Primary DI
10885380003530
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
ASU1145
Catalog number
ASU1145
Device description
Pulsewave Pump
Published
2016-08-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
BTAPUMP, PORTABLE, ASPIRATION (MANUAL OR POWERED)

Product Code Classifications

CodeDeviceSpecialtyClass
BTAPump, Portable, Aspiration (Manual Or Powered)General, Plastic Surgery2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10885380003530Direct MarkingGS10
50885380003538PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1088538000353010885380003530
5088538000353850885380003538

GMDN Terms

TermDefinition
Surgical irrigation/aspiration system pumpA mains electricity (AC-powered) device used to generate positive and/or negative pressures as part of an irrigation/aspiration system used during a general surgical procedure to intermittently or continuously irrigate and/or aspirate body cavities and wounds. It is not intended to be used for the administration of parenteral fluids, infusion of drugs, or for any life sustaining purposes.

Sterilization Methods

Method

Regulatory Flags

DUNS number
961027315
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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