FDA.reportPublic FDA data

COOLIEF* Cooled Radiofrequency Peristaltic Pump Unit

Primary DI
00193493993062
Brand
COOLIEF* Cooled Radiofrequency Peristaltic Pump Unit
Company
Avanos Medical, Inc.
Model
TDA-PPU-1
Catalog number
TDA-PPU-1
Device description
COOLIEF* Cooled Radiofrequency Peristaltic Pump Unit
Published
2021-04-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GEIElectrosurgical, cutting & coagulation & accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEIElectrosurgical, Cutting & Coagulation & AccessoriesGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00193493993062PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00193493993062001934939930621934939930620193493993062

GMDN Terms#

Term, Definition table
TermDefinition
Cooling utility supply systemAn assembly of devices designed to provide utilities/amenities (e.g., water, compressed air) to cool other medical devices, data equipment, or laboratory devices/equipment to facilitate their operation.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(844)428-2667PIQ@AVANOS.COM

Regulatory Flags#

DUNS number
079375431
Device count
1
Serial number
true

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