twiist

GUDID 00198617901008

Ambulatory insulin infusion pump/interstitial glucose monitoring system

Primary Device ID	00198617901008
NIH Device Record Key	2a41fa98-abb4-4b69-a3a6-1a099af0f92e
Commercial Distribution Status	In Commercial Distribution
Brand Name	twiist
Version Model Number	RF-90100
Company DUNS	119070341
Company Name	SEQUEL MED TECH, LLC
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	true
Serial Number	false
Manufacturing Date	false
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Issuing Agency	Device ID
GS1	00198617901008 [Primary]

QJI	Interoperable Automated Glycemic Controller

Steralize Prior To Use	false
Device Is Sterile	false

00198617904009	twiist Refill Kit without Infusion Set
00198617901008	twiist Refill Kit with Cleo Infusion Set
00198617101002	twiist Convenience Starter Kit with Cleo Infusion Set
00850017421431	twiist Disposable Cassette Pack (Sterile)
00850017421424	twiist Pump Starter Kit
00850017421400	twiist Pump Assembly, Labeled
00850017421479	twiist Replacement Pump Kit

Mark Image Registration \| Serial	Company Trademark Application Date
TWIIST 97979283 not registered Live/Pending	DEKA Research & Development Corp. 2023-02-27
TWIIST 97979282 not registered Live/Pending	DEKA Research & Development Corp. 2023-02-27
TWIIST 97812897 not registered Live/Pending	DEKA Research & Development Corp. 2023-02-27
TWIIST 97812874 not registered Live/Pending	DEKA Research & Development Corp. 2023-02-27
TWIIST 79354199 not registered Live/Pending	GEFRAN S.P.A. 2022-06-07