FDA.reportPublic FDA data

twiist

Primary DI
00198617901008
Brand
twiist
Company
SEQUEL MED TECH, LLC
Model
RF-90100
Device description
twiist Refill Kit with Cleo Infusion Set
Published
2024-09-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
QJIInteroperable Automated Glycemic Controller

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QJIInteroperable Automated Glycemic ControllerClinical Chemistry2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00198617901008PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00198617901008001986179010081986179010080198617901008

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
877-489-4478support@sequelmedtech.com
603-206-0591qa@millyardadvanced.com

Regulatory Flags#

DUNS number
119070341
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850017421608iiSure Infusion SetDKSP-10013-0002026-04-28
00850017421615iiSure Infusion SetDKSP-10014-0002026-04-28
00850017421479twiistDKPI-11098-0012025-04-30
00850017421448twiistDKPI-11099-0012025-04-10
00850017421400twiistDKPI-21073-0072025-04-10
00850017421424twiistDKPI-11029-0072025-04-10
00850017421431twiistDKPI-11073-0012025-04-10
00198617101002twiistCM-101002024-09-01
00198617904009twiistRF-904002024-09-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850050080374iLet Starter KitBeta Bionics, Inc.QJI2026-03-11
00389152858173Tandem t:slim Autosoft 30 KitTandem Diabetes Care, Inc.QJI2025-12-12
00389152858777Tandem t:slim Autosoft XC KitTandem Diabetes Care, Inc.QJI2025-12-12
00389152859477Tandem t:slimTruSteel KitTandem Diabetes Care, Inc.QJI2025-12-12
00389152856971Tandem t:slim Autosoft 30 KitTandem Diabetes Care, Inc.QJI2025-12-10
00389152857572Tandem t:slim Autosoft XC KitTandem Diabetes Care, Inc.QJI2025-12-10
10385083000411Omnipod 5 PodInsulet CorporationQJI2025-12-04
10385083000459Omnipod 5 Controller APPInsulet CorporationQJI2025-12-01
00389152707679Tandem t:slim Autosoft 30 kitTandem Diabetes Care, Inc.QJI2025-05-23
00389152708379Tandem t:slim AutoSoft XC KitTandem Diabetes Care, Inc.QJI2025-05-23
00389152708973Tandem t:slim Autosoft 30 kitTandem Diabetes Care, Inc.QJI2025-05-23
00389152709574Tandem t:slim AutoSoft XC KitTandem Diabetes Care, Inc.QJI2025-05-23
00389152710174Tandem t:slimTruSteel KitTandem Diabetes Care, Inc.QJI2025-05-23
00850017421479twiistSEQUEL MED TECH, LLCQJI2025-04-30
00850017421448twiistSEQUEL MED TECH, LLCQJI2025-04-10
00850017421400twiistSEQUEL MED TECH, LLCQJI2025-04-10
00850017421424twiistSEQUEL MED TECH, LLCQJI2025-04-10
00850017421431twiistSEQUEL MED TECH, LLCQJI2025-04-10
00850050080084"iLet Starter Kit - Inset 23"""Beta Bionics, Inc.QJI2024-11-13
00850050080114"iLet Starter Kit - Inset 32"""Beta Bionics, Inc.QJI2024-11-13
00850050080237iLet Starter Kit - Contact DetachBeta Bionics, Inc.QJI2024-11-13
00850050080190iLet Bionic PancreasBeta Bionics, Inc.QJI2024-11-07
00850050080183 iLet Bionic PancreasBeta Bionics, Inc.QJI2024-11-06
00850050080206 iLet Bionic PancreasBeta Bionics, Inc.QJI2024-11-06
00198617101002twiistSEQUEL MED TECH, LLCQJI2024-09-01
00198617904009twiistSEQUEL MED TECH, LLCQJI2024-09-01
10385083000336Omnipod 5 Controller APPInsulet CorporationQJI2024-07-22
00389152408170Tandem Mobi Starter KitTandem Diabetes Care, Inc.QJI2024-06-21
00389152311777Tandem Mobi Starter KitTandem Diabetes Care, Inc.QJI2024-03-27
10385083000527Omnipod 5 PodInsulet CorporationQJI2024-02-22