FDA.reportPublic FDA data

"iLet Starter Kit - Inset 32"""

Primary DI
00850050080114
Brand
"iLet Starter Kit - Inset 32"""
Company
Beta Bionics, Inc.
Model
Insulin Only
Catalog number
BB1006
Device description
iLet Bionic Pancreas Starter Kit with consumables (Pharmacy Starter Kit)
Published
2024-11-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FMFSyringe, Piston
FMINeedle, Hypodermic, Single Lumen
FPASet, Administration, Intravascular
JKATubes, Vials, Systems, Serum Separators, Blood Collection
QFGAlternate Controller Enabled Insulin Infusion Pump
QJIInteroperable Automated Glycemic Controller

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMFSyringe, PistonGeneral Hospital2
FMINeedle, Hypodermic, Single LumenGeneral Hospital2
FPASet, Administration, IntravascularGeneral Hospital2
JKATubes, Vials, Systems, Serum Separators, Blood CollectionClinical Chemistry2
QFGAlternate Controller Enabled Insulin Infusion PumpClinical Chemistry2
QJIInteroperable Automated Glycemic ControllerClinical Chemistry2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850050080114PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850050080114008500500801148500500801140850050080114

GMDN Terms#

Term, Definition table
TermDefinition
Ambulatory insulin infusion pump/interstitial glucose monitoring systemAn 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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
855-745-3800xx@xx.xx

Regulatory Flags#

DUNS number
835742136
Device count
1
Kit
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850050080374iLet Starter KitInsulin OnlyBB10182026-03-11
00850050080084"iLet Starter Kit - Inset 23"""Insulin OnlyBB10052024-11-13
00850050080237iLet Starter Kit - Contact DetachInsulin OnlyBB10082024-11-13
00850050080190iLet Bionic PancreasInsulin OnlyBB10032024-11-07
00850050080183 iLet Bionic PancreasInsulin OnlyBB10022024-11-06
00850050080206 iLet Bionic PancreasInsulin OnlyBB10042024-11-06
00850050080022 iLet Bionic PancreasInsulin OnlyBB10042023-06-14
00850050080039iLet Bionic PancreasInsulin OnlyBB10032023-06-14
00850050080046 iLet Bionic PancreasInsulin OnlyBB10022023-06-14
00850050080367iLet Insulin Infusion KitInsulin OnlyBB10172026-03-11
00850050080381iLet Insulin Infusion KitInsulin OnlyBB10192026-03-11
00850050080282iLet Inset Insulin Infusion Set (23”, 6mm)Insulin OnlyBB10102025-06-27
00850050080299iLet Contact Detach Insulin Infusion Set (23”, 6mm)Insulin OnlyBB10122025-06-27
00850050080305iLet Inset Insulin Infusion Set (32”, 6mm)Insulin OnlyBB10112025-06-27
05705244025226iLet Inset Insulin Infusion Set (23”, 6mm)Insulin OnlyBB10102025-06-27
05705244025288iLet Contact Detach Insulin Infusion Set (23”, 6mm)Insulin OnlyBB10122025-06-27
05705244026278iLet Inset Insulin Infusion Set (32”, 6mm)Insulin OnlyBB10112025-06-27
00850050080145iLet Connect Adapter 15-Pack (BB3052)Insulin OnlyBB30522024-11-13
00850050080138iLet Cartridge Kit 15-Pack (1.6mL/160 Units) Insulin OnlyBB20522024-11-13
00850050080169Bionic Circle App, iOSBOM000082BB50012024-11-13

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