AccessGUDID - DEVICE: PRISMAFLEX TPE 2000 SET (07332414111038)

GUDID

Device Identifier (DI) Information

Brand Name: PRISMAFLEX TPE 2000 SET
Version or Model: 114093
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 114093
Company Name: GAMBRO INDUSTRIES

Primary DI Number: 07332414111038
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 393020474 *Terms of Use

Device Description: The Prismaflex TPE2000 set is indicated for use only with the PrismaFlex control unit or with the PrisMax control unit (in countries where PrisMax is cleared or registered), after having selected TPE therapy. The Prismaflex TPE2000 set is intended for use in therapeutic plasma exchange, thus in diseases where removal of plasma components in indicated.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
36194	Apheresis system filter, whole blood	A sterile device designed to separate plasma from the cellular components of whole blood during manual/automated apheresis (the separation, collection, and reinfusion of blood) for donation of blood products or apheresis therapy. It typically contains a microporous membrane (usually with pores 0.2 to 0.6 micrometers) or a hollow-fibre column; it may also be intended to filter microorganisms and/or particles. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MDP	Separator For Therapeutic Purposes, Membrane Automated Blood Cell/Plasma

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P830063	006
P830063	009

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 0 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 214a1eb8-bc63-46c4-b586-c4d704367679
Public Version Date: August 10, 2023
Public Version Number: 8
DI Record Publish Date: March 23, 2017