AccessGUDID - DEVICE: H.E.L.P.® (04046964156731)

GUDID

Device Identifier (DI) Information

Brand Name: H.E.L.P.®
Version or Model: 4469
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 4469
Company Name: B.Braun Avitum AG

Primary DI Number: 04046964156731
Issuing Agency: GS1
Commercial Distribution End Date: October 13, 2021
Device Count: 2
Labeler D-U-N-S® Number*: 343689704 *Terms of Use

Device Description: H.E.L.P. ACETATPUFFER HOT US / CA

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 4 and 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Volume : 4000.000 ML
Device Size Text, specify: Acidity (pH) : 4.850 PH
Device Size Text, specify: Acetic acid 99% : 6.820 GLI
Device Size Text, specify: Sodium acetate x 3 H2O : 27.220 GLI

Device Record Status

Public Device Record Key: 5da7c8fd-dd20-40a3-a554-6336e3972547
Public Version Date: October 15, 2021
Public Version Number: 5
DI Record Publish Date: March 09, 2016

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: 04046964156724 CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(800)227-2862
Email: BBMUS_Service.EmailOrders@bbraun.com

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