FDA.report

TRIMA ACCEL PROCEDURE SUMMARY (TAPS) INTERFACE

Primary DI
05020583940109
Brand
TRIMA ACCEL PROCEDURE SUMMARY (TAPS) INTERFACE
Company
TERUMO BCT, INC.
Model
94010
Device description
TRIMA ACCEL PROCEDURE SUMMARY (TAPS) INTERFACE – Lite
Published
2016-09-15
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

Contact Domains

Product Codes

CodeName
OUGMedical device data system

Product Code Classifications

CodeDeviceSpecialtyClass
OUGMedical Device Data SystemGeneral Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
05020583940109PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05020583940109050205839401095020583940109

GMDN Terms

TermDefinition
Apheresis systemAn assembly of electrically-powered devices designed for the extracorporeal separation and removal of a constituent of whole blood (e.g., plasma, platelets, leukocytes) and pathogens, and the return of the remaining constituents to the patient. It typically includes pumps to circulate the blood and uses methods such as membrane filtration, centrifugation, adsorption, or a combination of these to separate the constituent from the blood. The system may be used therapeutically (e.g., to remove immune complexes or low density lipoproteins) or for the harvesting of blood constituents (e.g., for HLA-matched platelets or fresh frozen plasma).

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius40 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
+1(303)205-2510FDAUDIprogram@terumobct.com

Regulatory Flags

DUNS number
801679200
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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