AccessGUDID - DEVICE: Aquaboss® (04046964859861)

GUDID

Device Identifier (DI) Information

Brand Name: Aquaboss®
Version or Model: LA2050411
Commercial Distribution Status: In Commercial Distribution
Catalog Number: LA2050411
Company Name: B.Braun Avitum AG

Primary DI Number: 04046964859861
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 343689704 *Terms of Use

Device Description: HOT RINSE SMART 10 HYDRAULIC UNIT

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:	No
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?
62203	Haemodialysis water purification system washer-disinfector (thermal)	An electrically-powered unit intended to heat water and pump the hot water into the ringline/pipeline of a reverse-osmosis haemodialysis water purification system for cleaning and disinfection. It typically consists of a heater, pump, and connectors.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FIP	SUBSYSTEM, WATER PURIFICATION

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: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Handling Environment Atmospheric Pressure: between 70 and 106 KiloPascal
Handling Environment Humidity: less than 75 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure: between 70 and 106 KiloPascal
Storage Environment Temperature: between 5 and 40 Degrees Celsius
Storage Environment Humidity: less than 75 Percent (%) Relative Humidity
Handling Environment Temperature: between 5 and 40 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 659c051b-93ee-4fb5-a3fe-650429802996
Public Version Date: October 18, 2023
Public Version Number: 9
DI Record Publish Date: September 23, 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: No Unit of Use DI Numbers Found 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: No
Serial Number: Yes
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(800)848-2066
Email: rtd.us@bbraun.com

MENU
- Home
- About
- News
- API
- Download
- Help

FDA TOOLS & RESOURCES