AccessGUDID - DEVICE: ABACUS (05413765577352)

GUDID

Device Identifier (DI) Information

Brand Name: ABACUS
Version or Model: 83003392
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 83003392
Company Name: BAXTER HEALTHCARE CORPORATION

Primary DI Number: 05413765577352
Issuing Agency: GS1
Commercial Distribution End Date: May 31, 2029
Device Count: 1
Labeler D-U-N-S® Number*: 005083209 *Terms of Use

Device Description: ABACUS ORDER ENTRY & CALCULATION SOFTWARE VERSIONS 3.3.X SE

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?
17459	Intravenous solution compounder	A device that is typically exclusively used in the clinical pharmacy or a manufacturing plant for the production of intravenous (IV) fluids. These fluids will typically be distributed using the appropriate containers.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NEP	SYSTEM/DEVICE, PHARMACY COMPOUNDING

FDA Premarket Submission

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

Device Exempt from Premarket Submission: Yes 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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 01103956-b78c-4281-99a2-e423967b66ae
Public Version Date: July 21, 2023
Public Version Number: 6
DI Record Publish Date: July 01, 2019