AccessGUDID - DEVICE: Accu-Chek Rapid-D (04015630046720)

GUDID

Device Identifier (DI) Information

Brand Name: Accu-Chek Rapid-D
Version or Model: 04541111001
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 04541111001
Company Name: Roche Diabetes Care GmbH

Primary DI Number: 04015630046720
Issuing Agency: GS1
Commercial Distribution End Date: January 14, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 313212471 *Terms of Use

Device Description: Accu-Chek Rapid-D 6/110 15+5+5pcs

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:	Yes
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: a1a82f4e-59b5-45c1-92b8-fefce2b04257
Public Version Date: January 15, 2021
Public Version Number: 3
DI Record Publish Date: August 24, 2016