ETHICON ENDO-SURGERY, INC.

ETHICON ENDO-SURGERY, INC.

Address:3801 University Blvd SE,ALBUQUERQUE,NM,87106,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

Computer-assisted personalized sedation system (PDR) (10)

Premarket Exempt

No

Clear

SEDASYS - 10705036003434 Catalog Number : SEDCAS01

Device Description : SEDASYS DRUG DELIVERY CASSETTE

Device Class : 3

Duns Number: 123407392

Premarket Exempt : No

Product Code : PDR

Prescription Use : Yes

Device Count : 1

SEDASYS - 10705036010180 Catalog Number : SEDBMU01

Device Description : SEDASYS BEDSIDE MONITORING UNIT

Device Class : 3

Duns Number: 123407392

Premarket Exempt : No

Product Code : PDR

Prescription Use : Yes

Device Count : 1

SEDASYS - 10705036010203 Catalog Number : SEDPRU01

Device Description : SEDASYS CONTROL UNIT

Device Class : 3

Duns Number: 123407392

Premarket Exempt : No

Product Code : PDR

Prescription Use : Yes

Device Count : 1

SEDASYS - 10705036010210 Catalog Number : SEDPSU01

Device Description : SEDASYS POWER SUPPLY UNIT

Device Class : 3

Duns Number: 123407392

Premarket Exempt : No

Product Code : PDR

Prescription Use : Yes

Device Count : 1

SEDASYS - 20705036003554 Catalog Number : SED8UC

Device Description : SEDASYS UMBILICAL CABLE

Device Class : 3

Duns Number: 123407392

Premarket Exempt : No

Product Code : PDR

Prescription Use : Yes

Device Count : 1

SEDASYS - 20705036003561 Catalog Number : SEDARM01

Device Description : SEDASYS AUTOMATED RESPONSIVENESS MONITOR

Device Class : 3

Duns Number: 123407392

Premarket Exempt : No

Product Code : PDR

Prescription Use : Yes

Device Count : 1

SEDASYS - 20705036003578 Catalog Number : SEDBP6EC

Device Description : NIBP Extension

Device Class : 3

Duns Number: 123407392

Premarket Exempt : No

Product Code : PDR

Prescription Use : Yes

Device Count : 1

SEDASYS - 20705036003585 Catalog Number : SEDBPA

Device Description : NIBP Cuff - Adult

Device Class : 3

Duns Number: 123407392

Premarket Exempt : No

Product Code : PDR

Prescription Use : Yes

Device Count : 1

SEDASYS - 20705036003592 Catalog Number : SEDBPAL

Device Description : NIBP Cuff - Adult Large

Device Class : 3

Duns Number: 123407392

Premarket Exempt : No

Product Code : PDR

Prescription Use : Yes

Device Count : 1

SEDASYS - 20705036003608 Catalog Number : SEDBPAP

Device Description : NIBP Cuff - Adult Thigh

Device Class : 3

Duns Number: 123407392

Premarket Exempt : No

Product Code : PDR

Prescription Use : Yes

Device Count : 1

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