iLet Bionic Pancreas BB1003

GUDID 00850050080039

iLet Bionic Pancreas (Government Starter Kit)

Beta Bionics, Inc.

Ambulatory insulin infusion pump/interstitial glucose monitoring system Ambulatory insulin infusion pump/interstitial glucose monitoring system Ambulatory insulin infusion pump/interstitial glucose monitoring system Ambulatory insulin infusion pump/interstitial glucose monitoring system Ambulatory insulin infusion pump/interstitial glucose monitoring system Ambulatory insulin infusion pump/interstitial glucose monitoring system Ambulatory insulin infusion pump/interstitial glucose monitoring system Ambulatory insulin infusion pump/interstitial glucose monitoring system Ambulatory insulin infusion pump/interstitial glucose monitoring system Ambulatory insulin infusion pump/interstitial glucose monitoring system Ambulatory insulin infusion pump/interstitial glucose monitoring system Ambulatory insulin infusion pump/interstitial glucose monitoring system Ambulatory insulin infusion pump/interstitial glucose monitoring system Ambulatory insulin infusion pump/interstitial glucose monitoring system Ambulatory insulin infusion pump/interstitial glucose monitoring system Ambulatory insulin infusion pump/interstitial glucose monitoring system Ambulatory insulin infusion pump/interstitial glucose monitoring system Ambulatory insulin infusion pump/interstitial glucose monitoring system Ambulatory insulin infusion pump/interstitial glucose monitoring system Ambulatory insulin infusion pump/interstitial glucose monitoring system Ambulatory insulin infusion pump/interstitial glucose monitoring system Ambulatory insulin infusion pump/interstitial glucose monitoring system Ambulatory insulin infusion pump/interstitial glucose monitoring system Ambulatory insulin infusion pump/interstitial glucose monitoring system Ambulatory insulin infusion pump/interstitial glucose monitoring system Ambulatory insulin infusion pump/interstitial glucose monitoring system Ambulatory insulin infusion pump/interstitial glucose monitoring system Ambulatory insulin infusion pump/interstitial glucose monitoring system Ambulatory insulin infusion pump/interstitial glucose monitoring system Ambulatory insulin infusion pump/interstitial glucose monitoring system Ambulatory insulin infusion pump/interstitial glucose monitoring system Ambulatory insulin infusion pump/interstitial glucose monitoring system Ambulatory insulin infusion pump/interstitial glucose monitoring system

Primary Device ID	00850050080039
NIH Device Record Key	68f580af-2302-4338-b784-9edc40379cd7
Commercial Distribution Status	In Commercial Distribution
Brand Name	iLet Bionic Pancreas
Version Model Number	Insulin Only
Catalog Number	BB1003
Company DUNS	835742136
Company Name	Beta Bionics, Inc.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	MR Unsafe
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	false
Serial Number	true
Manufacturing Date	true
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Customer Support Contacts

Phone	855-745-3800
Email	xx@xx.xx
Phone	855-745-3800
Email	xx@xx.xx
Phone	855-745-3800
Email	xx@xx.xx
Phone	855-745-3800
Email	xx@xx.xx
Phone	855-745-3800
Email	xx@xx.xx
Phone	855-745-3800
Email	xx@xx.xx
Phone	855-745-3800
Email	xx@xx.xx
Phone	855-745-3800
Email	xx@xx.xx
Phone	855-745-3800
Email	xx@xx.xx
Phone	855-745-3800
Email	xx@xx.xx
Phone	855-745-3800
Email	xx@xx.xx
Phone	855-745-3800
Email	xx@xx.xx
Phone	855-745-3800
Email	xx@xx.xx
Phone	855-745-3800
Email	xx@xx.xx
Phone	855-745-3800
Email	xx@xx.xx
Phone	855-745-3800
Email	xx@xx.xx
Phone	855-745-3800
Email	xx@xx.xx
Phone	855-745-3800
Email	xx@xx.xx
Phone	855-745-3800
Email	xx@xx.xx
Phone	855-745-3800
Email	xx@xx.xx
Phone	855-745-3800
Email	xx@xx.xx
Phone	855-745-3800
Email	xx@xx.xx
Phone	855-745-3800
Email	xx@xx.xx
Phone	855-745-3800
Email	xx@xx.xx
Phone	855-745-3800
Email	xx@xx.xx
Phone	855-745-3800
Email	xx@xx.xx
Phone	855-745-3800
Email	xx@xx.xx
Phone	855-745-3800
Email	xx@xx.xx
Phone	855-745-3800
Email	xx@xx.xx
Phone	855-745-3800
Email	xx@xx.xx
Phone	855-745-3800
Email	xx@xx.xx
Phone	855-745-3800
Email	xx@xx.xx
Phone	855-745-3800
Email	xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850050080039 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K220916

FDA Product Code

QJI	Interoperable Automated Glycemic Controller

Sterilization

Steralize Prior To Use	false
Device Is Sterile	false

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2023-06-22
Device Publish Date	2023-06-14

Devices Manufactured by Beta Bionics, Inc.

00850050080121 - iLet Insulin Infusion Kit – Contact Detach™ (23"", 6mm) - 20-Pack	2023-08-17 Pharmacy kit for use with the iLet Bionic Pancreas
00850050080022 - iLet Bionic Pancreas	2023-06-22 iLet Bionic Pancreas (Pharmacy Starter Kit)
00850050080039 - iLet Bionic Pancreas	2023-06-22iLet Bionic Pancreas (Government Starter Kit)
00850050080039 - iLet Bionic Pancreas	2023-06-22 iLet Bionic Pancreas (Government Starter Kit)
00850050080046 - iLet Bionic Pancreas	2023-06-22 iLet Bionic Pancreas (Commercial Starter Kit)
00850050080053 - iLet Cartridge Kit	2023-06-22 For use with the iLet Bionic Pancreas
00850050080077 - iLet Connect Adapter	2023-06-22 For use with the iLet Bionic Pancreas
00850050080107 - iLet Insulin Infusion Kit – Inset™ (23", 6mm) 10-Pack	2023-06-22 Pharmacy kit for use with the iLet Bionic Pancreas

Trademark Results [iLet Bionic Pancreas]

Mark Image Registration \| Serial	Company Trademark Application Date
ILET BIONIC PANCREAS 97893020 not registered Live/Pending	BETA BIONICS, INC. 2023-04-18