AccessGUDID - DEVICE: Accu-Chek Ultraflex (04015630049943)

GUDID

Device Identifier (DI) Information

Brand Name: Accu-Chek Ultraflex
Version or Model: 04626605001
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 04626605001
Company Name: Roche Diabetes Care GmbH

Primary DI Number: 04015630049943
Issuing Agency: GS1
Commercial Distribution End Date: August 23, 2021
Device Count: 10
Labeler D-U-N-S® Number*: 313212471 *Terms of Use

Device Description: Accu-Chek Ultraflex I 8/110 10pcs

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:	Yes
Prescription Use (Rx):	No
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?
35833	Electric infusion pump administration set, single-use	A collection of sterile devices (e.g., plastic tubing, check valve, roller clamp, Y-site connector, Luer, needle/catheter) intended to be used in combination with an electrically-powered infusion pump for the intravenous (IV), subcutaneous, intramuscular, or epidural administration of medication. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FPA	Set, Administration, Intravascular

FDA Premarket Submission

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

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Ethylene Oxide

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: 9311a8fd-e555-48b8-9400-23636ce64085
Public Version Date: July 25, 2023
Public Version Number: 4
DI Record Publish Date: August 25, 2016