AccessGUDID - DEVICE: Tandem Mobi Adhesive Sleeve (00389152076157)

GUDID

Device Identifier (DI) Information

Brand Name: Tandem Mobi Adhesive Sleeve
Version or Model: 1010123
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Tandem Diabetes Care, Inc.

Primary DI Number: 00389152076157
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 10
Labeler D-U-N-S® Number*: 827900809 *Terms of Use

Device Description: No description.

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?
64891	Ambulatory insulin infusion pump, electronic, software-dosing, scalar algorithm	A portable electronic device designed to provide continuous or intermittent subcutaneous delivery of insulin to a patient with diabetes mellitus, incorporating software to receive glucose status data from a monitor/transmitter and to determine the delivery of insulin based on a continuous scalar algorithm. It may be badge-like, designed to adhere to skin or clothing or worn in a case attached to the belt or carried in a pocket and includes a reservoir, a pumping mechanism, and an infusion-rate controller. It may also allow additional manual administration/infusion and functionality to send data to a remote reporting system.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KGX	Tape And Bandage, Adhesive

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: cf950fc4-c497-4615-8600-a751316afac0
Public Version Date: December 13, 2023
Public Version Number: 1
DI Record Publish Date: December 05, 2023