AccessGUDID - DEVICE: DianaTM Compounding Workflow System (00887709126770)

GUDID

Device Identifier (DI) Information

Brand Name: DianaTM Compounding Workflow System
Version or Model: DS2800-04-01
Commercial Distribution Status: In Commercial Distribution
Catalog Number: DS2800-04-01
Company Name: ICU MEDICAL, INC.

Primary DI Number: 00887709126770
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 118380146 *Terms of Use

Device Description: Diana Web Server 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?
16807	Pharmaceutical fluid-dispensing system	A assembly of devices used in a hospital and/or other healthcare facility to dispense fluids by combining in a given ratio several liquid components from a set of source containers into a container with the final product (i.e., it compounds drugs according to a specified medical prescription). It is typically a mains electricity (AC-powered) automated or semi-automated device that includes a set of standardized source liquid containers each attached with tubes to a compounding device which output is in turn attached to the final liquid container. It may also include a control panel to facilitate the introduction of manual or bar-coded mixing and/or checking instructions.	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
Special Storage Condition, Specify: Handling Environment Temperature
Storage Environment Temperature: between 0 and 60 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 0563b288-b938-40ba-8a0d-3dd9b8fa7f42
Public Version Date: April 18, 2023
Public Version Number: 1
DI Record Publish Date: April 10, 2023