CYGNUS MEDICAL L.L.C.

Address:965 W Main St,Branford,CT,06405,US

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Unit, Drying (JRJ) (6) Accessories, Cleaning Brushes, For Endoscope (MNL) (2) Carrier, Ligature (GEJ) (1) General Purpose Instrument Tray (PXV) (1)

Premarket Exempt

Yes

Clear

Luer Lock Adapter and Suction Tube Adapter - 00843356102291 Catalog Number :

Device Description : Luer Lock Adapter and Suction Tube Adapter (bulk packaged pairs), Single Use - 2 Luer Lock Adapter and Suction Tube Adapter (bulk packaged pairs), Single Use - 25 luer lock/suction tube pairs per bag

Device Class :

Duns Number: 103169095

Premarket Exempt : Yes

Product Code : JRJ

Prescription Use : No

Device Count : 25

Airtime Directional Flow Tubing Set - 00843356102307 Catalog Number :

Device Description : Airtime Directional Flow Tubing Set - 1 tubing set

Device Class : 1

Duns Number: 103169095

Premarket Exempt : Yes

Product Code : JRJ

Prescription Use : No

Device Count : 1

Airtime Small Diameter Scope Tubing Set - 00843356102314 Catalog Number :

Device Description : Airtime Small Diameter Scope Tubing Set, single-line - 2 tubing sets per bag

Device Class :

Duns Number: 103169095

Premarket Exempt : Yes

Product Code : JRJ

Prescription Use : No

Device Count : 2

Airtime Small Diameter Scope Tubing Set - 00843356102321 Catalog Number :

Device Description : Airtime Small Diameter Scope Tubing Set, dual-line. 2 tubing sets with Y connector per bag

Device Class :

Duns Number: 103169095

Premarket Exempt : Yes

Product Code : JRJ

Prescription Use : No

Device Count : 5

Airtime Small Diameter Scope Tubing Set - 00843356102338 Catalog Number :

Device Description : Airtime Small Diameter Scope Tubing Set, dual-line - 2 tubing sets per bag

Device Class :

Duns Number: 103169095

Premarket Exempt : Yes

Product Code : JRJ

Prescription Use : No

Device Count : 2

Oasis Biodegradable Tray - 00843356102345 Catalog Number :

Device Description : Oasis Biodegradable Tray with center reservoir and reversible four tab lid. Con Oasis Biodegradable Tray with center reservoir and reversible four tab lid. Constructed with virgin biodegradable fiber - 30 trays & 30 lids

Device Class : 1

Duns Number: 103169095

Premarket Exempt : Yes

Product Code : PXV

Prescription Use : No

Device Count : 30

Airtime Small Bore Adapter - 00843356102352 Catalog Number :

Device Description : Airtime Small Bore Adapter, 25 Adapters per Bag. 12 bags of 25 Adapters per Case Airtime Small Bore Adapter, 25 Adapters per Bag. 12 bags of 25 Adapters per Case. (Ref: Fisnar # 8001268, 14 gauge)

Device Class :

Duns Number: 103169095

Premarket Exempt : Yes

Product Code : JRJ

Prescription Use : No

Device Count : 25

Microfiber Endoscopic Channel Brush - 00843356102369 Catalog Number :

Device Description : Microfiber Endoscopic Channel Brush, 2.8mm - 3.2mm, 1 Brush

Device Class : 1

Duns Number: 103169095

Premarket Exempt : Yes

Product Code : MNL

Prescription Use : No

Device Count : 1

Basic Needs Kit, EP4, BP500, WS100, 4412H (10pk) & 879 - 00843356102406 Catalog Number :

Device Description : Basic Needs Kit, EP4, BP500, WS100, 4412H (10pk) & 879 - 1 Kit

Device Class :

Duns Number: 103169095

Premarket Exempt : Yes

Product Code : MNL

Prescription Use : No

Device Count : 1

INSTRUMENT TRANSPORT BAG - 00843356102413 Catalog Number :

Device Description : INSTRUMENT TRANSPORT BAG 12'' x 18'', 2MIL RESEALABLE COMPOSTABLE BAG PRINTED W/ INSTRUMENT TRANSPORT BAG 12'' x 18'', 2MIL RESEALABLE COMPOSTABLE BAG PRINTED W/ HIGH LEVEL DISINFECTED LABEL - 100 TRANSPORT BAGS PER CARRIER

Device Class :

Duns Number: 103169095

Premarket Exempt : Yes

Product Code : GEJ

Prescription Use : No

Device Count : 100

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