FDA.reportPublic FDA data

iLet Contact Detach Insulin Infusion Set (23”, 6mm)

Primary DI
00850050080299
Brand
iLet Contact Detach Insulin Infusion Set (23”, 6mm)
Company
Beta Bionics, Inc.
Model
Insulin Only
Catalog number
BB1012
Device description
Insulin Infusion Sets for use with the iLet Bionic Pancreas
Published
2025-06-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FPASet, Administration, Intravascular

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FPASet, Administration, IntravascularGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K041545000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K041545000CONTACT DETACHUnomedical A/S2004-06-30FPA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850050080299PrimaryGS10
05705244025288Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850050080299008500500802998500500802990850050080299
05705244025288057052440252885705244025288

GMDN Terms#

Term, Definition table
TermDefinition
Electric infusion pump administration set, single-useA collection of sterile devices (e.g., plastic tubing, check valve, roller clamp, Y-site connector, Luer, needle/catheter) intended to be used in combination with an electrically-powered infusion pump for the intravenous (IV), subcutaneous, intramuscular, or epidural administration of medication. This is a single-use device.

Contacts#

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

Regulatory Flags#

DUNS number
835742136
Device count
2
Lot or batch
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
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
00850050080114"iLet Starter Kit - Inset 32"""Insulin OnlyBB10062024-11-13
00850050080138iLet Cartridge Kit 15-Pack (1.6mL/160 Units) Insulin OnlyBB20522024-11-13
00850050080169Bionic Circle App, iOSBOM000082BB50012024-11-13

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