AccessGUDID - DEVICE: ElDorado Donor 3.x.x (00860007282713)

GUDID

Device Identifier (DI) Information

Brand Name: ElDorado Donor 3.x.x
Version or Model: 3.x.x
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Gpi Usa, Inc.

Primary DI Number: 00860007282713
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 117765002 *Terms of Use
Previous DI: 00812747010149

Device Description: ElDorado Donor 3.x.x

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?
36149	Blood bank information system	A dedicated assembly of devices designed to electronically receive, collect, store, manage, assist in analysis of, display, and/or distribute administrative and/or clinical data within blood-bank centres. Specific functions typically include management of blood-donor data, autologous and direct blood unit tracking (e.g., using radio-frequency identification (RFID)], and/or cross-match result determination. It consists of dedicated combined hardware (e.g., computers, terminals, network components, blood unit containers) and software.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MMH	Blood Establishment Computer Software And Accessories

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
BK150308	0

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: ee3a48c0-13ab-4c37-9b4c-c131bb938d5d
Public Version Date: August 23, 2021
Public Version Number: 1
DI Record Publish Date: August 13, 2021