AccessGUDID - DEVICE: EXACTAMIX (00085412486253)

GUDID

Device Identifier (DI) Information

Brand Name: EXACTAMIX
Version or Model: H938EXACTA-VLS
Commercial Distribution Status: In Commercial Distribution
Catalog Number: H938EXACTA-VLS
Company Name: BAXTER HEALTHCARE CORPORATION

Primary DI Number: 00085412486253
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 005083209 *Terms of Use

Device Description: EXACTAMIX Compounder, Long Vial Rack, Short Rods

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
Handling Environment Humidity: between 10 and 80 Percent (%) Relative Humidity
Storage Environment Humidity: between 10 and 80 Percent (%) Relative Humidity
Handling Environment Temperature: between 15 and 30 Degrees Celsius
Storage Environment Temperature: between 0 and 64 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 44136d5f-02ef-4e2b-a3d0-5d6becc5d9b1
Public Version Date: July 20, 2023
Public Version Number: 4
DI Record Publish Date: September 23, 2016