OnTrak 016-0077-05Q

GUDID 10841522102530

CUFF,ABP,LG ADLT,32-42CM/13-17IN,NO LTX,QKD/LUER

SPACELABS HEALTHCARE (WASHINGTON), INC

Blood pressure cuff, reusable
Primary Device ID10841522102530
NIH Device Record Keyb152e0b1-57f1-4cd1-bec8-37897e29ead2
Commercial Distribution StatusIn Commercial Distribution
Brand NameOnTrak
Version Model Number90227
Catalog Number016-0077-05Q
Company DUNS145581588
Company NameSPACELABS HEALTHCARE (WASHINGTON), INC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment TemperatureBetween -30 Degrees Celsius and 75 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Celsius and 75 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -30 Degrees Celsius and 75 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -30 Degrees Celsius and 75 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -30 Degrees Celsius and 75 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -30 Degrees Celsius and 75 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -30 Degrees Celsius and 75 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -30 Degrees Celsius and 75 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -30 Degrees Celsius and 75 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -30 Degrees Celsius and 75 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -30 Degrees Celsius and 75 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -30 Degrees Celsius and 75 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -30 Degrees Celsius and 75 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -30 Degrees Celsius and 75 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -30 Degrees Celsius and 75 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -30 Degrees Celsius and 75 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -30 Degrees Celsius and 75 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -30 Degrees Celsius and 75 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -30 Degrees Celsius and 75 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -30 Degrees Celsius and 75 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -30 Degrees Celsius and 75 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -30 Degrees Celsius and 75 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -30 Degrees Celsius and 75 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -30 Degrees Celsius and 75 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -30 Degrees Celsius and 75 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -30 Degrees Celsius and 75 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -30 Degrees Celsius and 75 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -30 Degrees Celsius and 75 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -30 Degrees Celsius and 75 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -30 Degrees Celsius and 75 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -30 Degrees Celsius and 75 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -30 Degrees Celsius and 75 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -30 Degrees Celsius and 75 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -30 Degrees Celsius and 75 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -30 Degrees Celsius and 75 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -30 Degrees Celsius and 75 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -30 Degrees Celsius and 75 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -30 Degrees Celsius and 75 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS110841522102530 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DXNSYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2020-04-03
Device Publish Date2016-11-21

On-Brand Devices [OnTrak]

10841522102547CUFF,ABP,XLGADLT,38-50CM/15-20IN,NO LTX,QKD/LEUR
10841522102530CUFF,ABP,LG ADLT,32-42CM/13-17IN,NO LTX,QKD/LUER
10841522102257CUFF,ABP,CHILD,12-20CM/5-8IN,NO LTX,QK DISC/LUER
10841522102240CUFF,ABP,ADLT,24-32CM/9-13IN,NO LTX,QK DISC/LUER
10841522102233CUFF,ABP,SM ADLT,17-26CM/7-10IN,NO LTX,QKD/LUER
10841522129261CUFF,ABP,ADULT,XL,38-50CM/15-20IN,NO LTX
10841522129247CUFF,ABP,CHILD,12-20CM/5-8IN,NO LTX

Trademark Results [OnTrak]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ONTRAK
ONTRAK
98077435 not registered Live/Pending
U. E. SYSTEMS INCORPORATED
2023-07-10
ONTRAK
ONTRAK
97900460 not registered Live/Pending
Rice Lake Weighing Systems, Inc.
2023-04-21
ONTRAK
ONTRAK
90100701 not registered Live/Pending
Ontrak, Inc.
2020-08-07
ONTRAK
ONTRAK
88861815 not registered Live/Pending
Catasys, Inc.
2020-04-06
ONTRAK
ONTRAK
88861808 not registered Live/Pending
Catasys, Inc.
2020-04-06
ONTRAK
ONTRAK
88150071 5762290 Live/Registered
Spacelabs Holdings, Inc.
2018-10-10
ONTRAK
ONTRAK
86406048 4708383 Live/Registered
Baker Hughes Incorporated
2014-09-25
ONTRAK
ONTRAK
78269184 3330405 Dead/Cancelled
Rice Lake Weighing Systems, Inc.
2003-07-01
ONTRAK
ONTRAK
78138887 2830788 Dead/Cancelled
D.C.D. Global, Inc.
2002-06-26
ONTRAK
ONTRAK
78082951 2815707 Dead/Cancelled
Baker Hughes Incorporated
2001-09-06
ONTRAK
ONTRAK
78082946 not registered Dead/Abandoned
Baker Hughes Incorporated
2001-09-06
ONTRAK
ONTRAK
78002872 not registered Dead/Abandoned
Lat-Lon, L.L.C.
2000-04-06

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