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) (5) Carrier, Ligature (GEJ) (3) Shield, Protective, Personnel (KPY) (2)

Premarket Exempt

Yes

Clear

MALE/FEMALE LUERLOCK - 00843356102543 Catalog Number :

Device Description : MALE/FEMALE LUERLOCK, LUERLOCK CAP 2'' SOFT TUBING - 1 set

Device Class : 1

Duns Number: 103169095

Premarket Exempt : Yes

Product Code : JRJ

Prescription Use : No

Device Count : 1

Airtime HEPA Filter Assembly Set, .010 micron Right Angle Connector - 00843356102550 Catalog Number :

Device Description : Airtime HEPA Filter Assembly Set, .010 micron Right Angle Connector - 1 package Airtime HEPA Filter Assembly Set, .010 micron Right Angle Connector - 1 package of 2 filters

Device Class : 1

Duns Number: 103169095

Premarket Exempt : Yes

Product Code : JRJ

Prescription Use : No

Device Count : 2

Airtime HEPA Filter Assembly Set, .010 micron Straight Line Connector - 00843356102567 Catalog Number :

Device Description : Airtime HEPA Filter Assembly Set, .010 micron STRAIGHT Line Connector - 1 packag Airtime HEPA Filter Assembly Set, .010 micron STRAIGHT Line Connector - 1 package of 2 filters

Device Class : 1

Duns Number: 103169095

Premarket Exempt : Yes

Product Code : JRJ

Prescription Use : No

Device Count : 2

AIRTIME DAILY TUBING SET - 00843356102581 Catalog Number :

Device Description : AIRTIME DAILY TUBING SET UNIVERSAL - 1 set

Device Class : 1

Duns Number: 103169095

Premarket Exempt : Yes

Product Code : JRJ

Prescription Use : No

Device Count : 1

INSTRUMENT TRANSPORT BAG - 00843356102598 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 Bags

Device Class :

Duns Number: 103169095

Premarket Exempt : Yes

Product Code : GEJ

Prescription Use : No

Device Count : 100

Airtime Directional Flow Tubing - 00843356102604 Catalog Number :

Device Description : Airtime Directional Flow Tubing - 1 Set

Device Class : 1

Duns Number: 103169095

Premarket Exempt : Yes

Product Code : JRJ

Prescription Use : No

Device Count : 1

Face Shield - 00843356102611 Catalog Number :

Device Description : Face Shield, Single Use Disposable - 1 Face Shield

Device Class : 1

Duns Number: 103169095

Premarket Exempt : Yes

Product Code : KPY

Prescription Use : No

Device Count : 1

Face Shield - 00843356102628 Catalog Number :

Device Description : Face Shield, Single Use Disposable - 36 Face Shields

Device Class :

Duns Number: 103169095

Premarket Exempt : Yes

Product Code : KPY

Prescription Use : No

Device Count : 36

INSTRUMENT TRANSPORT BAG - 00843356102635 Catalog Number :

Device Description : INSTRUMENT TRANSPORT BAG 20'' x 22'', 2MIL RESEALABLE COMPOSTABLE BAG PRINTED - INSTRUMENT TRANSPORT BAG 20'' x 22'', 2MIL RESEALABLE COMPOSTABLE BAG PRINTED - 25 BAGS PER CARRIER

Device Class :

Duns Number: 103169095

Premarket Exempt : Yes

Product Code : GEJ

Prescription Use : No

Device Count : 25

INSTRUMENT TRANSPORT BAG - 00843356102642 Catalog Number :

Device Description : INSTRUMENT TRANSPORT BAG 20'' x 22'', 2MIL RESEALABLE COMPOSTABLE BAG PRINTED W/ INSTRUMENT TRANSPORT BAG 20'' x 22'', 2MIL RESEALABLE COMPOSTABLE BAG PRINTED W/HIGH LEVEL DISINFECTED LABEL - 25 BAGS PER CARRIER

Device Class :

Duns Number: 103169095

Premarket Exempt : Yes

Product Code : GEJ

Prescription Use : No

Device Count : 25

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