SPACELABS HEALTHCARE (WASHINGTON), INC

Address:35301 SE Center St,Snoqualmie,WA,98065,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

DETECTOR AND ALARM, ARRHYTHMIA (DSI) (5) MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS) (MHX) (3) TRANSMITTERS AND RECEIVERS, ELECTROCARDIOGRAPH, TELEPHONE (DXH) (1) blood pressure cuff (DXQ) (1)

Premarket Exempt

Yes No

Clear

Trulink - 10841522100635 Catalog Number : 012-0283-02

Device Description : LDWR,SET,DIN,SNAP,3-LEAD,102CM/40IN,AAMI,1/ST

Device Class : 2

Duns Number: 145581588

Premarket Exempt : No

Product Code : DSI

Prescription Use : Yes

Device Count : 1

TRULINK - 10841522100642 Catalog Number : 012-0283-11

Device Description : LDWR SET,SNAP,DIN,ECG,61CM/24IN,AAMI,3LW/ST,1/ST

Device Class : 2

Duns Number: 145581588

Premarket Exempt : No

Product Code : MHX

Prescription Use : Yes

Device Count : 1

Trulink - 10841522100659 Catalog Number : 012-0284-00

Device Description : LDWR,SET,DIN,PNCH,3-LEAD,46CM/18IN,AAMI,1/ST

Device Class : 2

Duns Number: 145581588

Premarket Exempt : No

Product Code : DSI

Prescription Use : Yes

Device Count : 1

Trulink - 10841522100673 Catalog Number : 012-0284-02

Device Description : LDWR,SET,DIN,PNCH,3-LEAD,102CM/40IN,AAMI,1/ST

Device Class : 2

Duns Number: 145581588

Premarket Exempt : No

Product Code : DSI

Prescription Use : Yes

Device Count : 1

Digital Telemetry - 10841522100680 Catalog Number : 012-0284-11

Device Description : LDWR SET,PINCH,DIN,61CM/ 24 IN,AAMI,3LW/ST, 1/ST

Device Class : 2

Duns Number: 145581588

Premarket Exempt : No

Product Code : MHX

Prescription Use : Yes

Device Count : 1

Trulink - 10841522100697 Catalog Number : 012-0285-00

Device Description : LDWR,SET,DIN,SNAP,5-LEAD,46CM/18IN,AAMI,1/ST

Device Class : 2

Duns Number: 145581588

Premarket Exempt : No

Product Code : DSI

Prescription Use : Yes

Device Count : 1

SENTINEL - 10841522100710 Catalog Number : 98200 v10.0

Device Description : SENTINEL

Device Class : 2

Duns Number: 145581588

Premarket Exempt : No

Product Code : DXH

Prescription Use : No

Device Count : 1

TRULINK - 10841522100734 Catalog Number : 012-0285-11

Device Description : LDWR SET,SNAP,DIN,ECG,61CM/24IN,AAMI,5LW/ST,1/ST

Device Class : 2

Duns Number: 145581588

Premarket Exempt : No

Product Code : MHX

Prescription Use : Yes

Device Count : 1

Trulink - 10841522100741 Catalog Number : 012-0286-00

Device Description : LDWR,SET,DIN,PNCH,5-LEAD,46CM/18IN,AAMI,1/ST

Device Class : 2

Duns Number: 145581588

Premarket Exempt : No

Product Code : DSI

Prescription Use : Yes

Device Count : 1

TRULINK - 10841522100987 Catalog Number : 714-0020-00

Device Description : NIBP,CUFF,1TB,CHILD,12-19CM,NYLON,1/EA

Device Class : 2

Duns Number: 145581588

Premarket Exempt : No

Product Code : DXQ

Prescription Use : Yes

Device Count : 1

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