AccessGUDID - DEVICE: Soft-Release-O (07613117010386)

GUDID

Device Identifier (DI) Information

Brand Name: Soft-Release-O
Version or Model: S3061
Commercial Distribution Status: In Commercial Distribution
Catalog Number: S3061
Company Name: Ypsomed AG

Primary DI Number: 07613117010386
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 10
Labeler D-U-N-S® Number*: 481742760 *Terms of Use

Device Description: Soft-Release-O Infusion Set, 6 mm soft cannula, 30 cm (12") blue tubing. / Infusion set with a soft cannula designed to work with the DANA DIABECARE insulin pump.

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):	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?
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: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Length: 6.0 Millimeter

Device Record Status

Public Device Record Key: a4e98f65-32ff-46cc-8532-e9663108bf7e
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 24, 2016