AccessGUDID - DEVICE: H.E.L.P.® (04046964696770)

GUDID

Device Identifier (DI) Information

Brand Name: H.E.L.P.®
Version or Model: 7211101
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 7211101
Company Name: B.Braun Avitum AG

Primary DI Number: 04046964696770
Issuing Agency: GS1
Commercial Distribution End Date: February 14, 2018
Device Count: 20
Labeler D-U-N-S® Number*: 343689704 *Terms of Use

Device Description: HELP ULTRAFILTER HIPS 20 US

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":	No
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?
58091	Apheresis kit	A collection of sterile and disposable/consumable devices intended to be used to prepare for and perform (connect the patient) an apheresis treatment (e.g., immunoadsorption, plasmapheresis, plasma exchange) with an apheresis system. It typically consists of tubing, separation devices (e.g., adsorber, filter), and rinsing solutions for preparation of the extracorporeal circuit. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MMY	LIPOPROTEIN, LOW DENSITY, REMOVAL

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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
Device Size Text, specify: Max TMP (mmHg) : 600.000 MHG

Device Record Status

Public Device Record Key: 5b99d8c2-0c58-4dd2-9873-c9e1a4ac4920
Public Version Date: January 19, 2024
Public Version Number: 7
DI Record Publish Date: March 09, 2016