AccessGUDID - DEVICE: iLet Bionic Pancreas (00850050080206)

GUDID

Device Identifier (DI) Information

Brand Name: iLet Bionic Pancreas
Version or Model: Insulin Only
Commercial Distribution Status: In Commercial Distribution
Catalog Number: BB1004
Company Name: Beta Bionics, Inc.

Primary DI Number: 00850050080206
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 835742136 *Terms of Use

Device Description: iLet Bionic Pancreas (Pharmacy Starter Kit)

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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?
60770	Ambulatory insulin infusion pump/interstitial glucose monitoring system	An assembly of portable devices intended to simultaneously continuously monitor interstitial glucose levels and subcutaneously infuse insulin in patients with diabetes. Sometimes referred to as a closed loop artificial pancreas, it consists of a percutaneous blood glucose monitoring system (CGM), an ambulatory insulin infusion pump, and software on a dedicated handset or transmitter capable of telemetric communication with the other components. The software contains an algorithm to allow continuous communication between the two devices, and may enable the manual input of data with respect to meals and physical activity.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
QJI	Interoperable Automated Glycemic Controller
QFG	Alternate Controller Enabled Insulin Infusion Pump

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: 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: dc07bf13-dacc-4094-897c-5f5c8cc6e809
Public Version Date: November 14, 2024
Public Version Number: 1
DI Record Publish Date: November 06, 2024