AccessGUDID - DEVICE: DOSE IQ SAFETY SOFTWARE (00085412676616)

GUDID

Device Identifier (DI) Information

Brand Name: DOSE IQ SAFETY SOFTWARE
Version or Model: DOSEIQW0001
Commercial Distribution Status: In Commercial Distribution
Catalog Number: DOSEIQW0001
Company Name: BAXTER HEALTHCARE CORPORATION

Primary DI Number: 00085412676616
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 005083209 *Terms of Use

Device Description: Infusion Safety Management Software

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?
47903	Infusion pump medication-dosage application software	A software program intended to enable a healthcare professional to create, modify and store (manage) dosage parameters (protocols) for delivery of medication by an electronic infusion pump(s) or a syringe pump(s) which is used in a hospital/institution (e.g., IV pole mounted) or used for ambulatory purposes [also known as computerized ambulatory drug delivery (CADD)].	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PHC	Infusion Safety Management Software

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K211124	000

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 77036b60-7f61-4292-b5b5-f2ad4e92a743
Public Version Date: July 19, 2023
Public Version Number: 3
DI Record Publish Date: September 22, 2022