iLet Bionic Pancreas BB1002
GUDID 00850050080046
iLet Bionic Pancreas (Commercial 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 | 00850050080046 |
| NIH Device Record Key | 5a63df64-973f-4265-9b01-8b06288598de |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | iLet Bionic Pancreas |
| Version Model Number | Insulin Only |
| Catalog Number | BB1002 |
| 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 |
| xx@xx.xx | |
| Phone | 855-745-3800 |
| xx@xx.xx | |
| Phone | 855-745-3800 |
| xx@xx.xx | |
| Phone | 855-745-3800 |
| xx@xx.xx | |
| Phone | 855-745-3800 |
| xx@xx.xx | |
| Phone | 855-745-3800 |
| xx@xx.xx | |
| Phone | 855-745-3800 |
| xx@xx.xx | |
| Phone | 855-745-3800 |
| xx@xx.xx | |
| Phone | 855-745-3800 |
| xx@xx.xx | |
| Phone | 855-745-3800 |
| xx@xx.xx | |
| Phone | 855-745-3800 |
| xx@xx.xx | |
| Phone | 855-745-3800 |
| xx@xx.xx | |
| Phone | 855-745-3800 |
| xx@xx.xx | |
| Phone | 855-745-3800 |
| xx@xx.xx | |
| Phone | 855-745-3800 |
| xx@xx.xx | |
| Phone | 855-745-3800 |
| xx@xx.xx | |
| Phone | 855-745-3800 |
| xx@xx.xx | |
| Phone | 855-745-3800 |
| xx@xx.xx | |
| Phone | 855-745-3800 |
| xx@xx.xx | |
| Phone | 855-745-3800 |
| xx@xx.xx | |
| Phone | 855-745-3800 |
| xx@xx.xx | |
| Phone | 855-745-3800 |
| xx@xx.xx | |
| Phone | 855-745-3800 |
| xx@xx.xx | |
| Phone | 855-745-3800 |
| xx@xx.xx | |
| Phone | 855-745-3800 |
| xx@xx.xx | |
| Phone | 855-745-3800 |
| xx@xx.xx | |
| Phone | 855-745-3800 |
| xx@xx.xx | |
| Phone | 855-745-3800 |
| xx@xx.xx | |
| Phone | 855-745-3800 |
| xx@xx.xx | |
| Phone | 855-745-3800 |
| xx@xx.xx | |
| Phone | 855-745-3800 |
| xx@xx.xx | |
| Phone | 855-745-3800 |
| xx@xx.xx | |
| Phone | 855-745-3800 |
| xx@xx.xx |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850050080046 [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 |
On-Brand Devices [ iLet Bionic Pancreas]
| 00850050080046 | iLet Bionic Pancreas (Commercial Starter Kit) |
| 00850050080022 | iLet Bionic Pancreas (Pharmacy Starter Kit) |
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 |
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