Spacelabs 016-0077-07Q

GUDID 10841522129612

CUFF,ABP,ADULT,L,32-42CM/13-17IN,NO LTX

SPACELABS HEALTHCARE (WASHINGTON), INC

Blood pressure ambulatory recorder
Primary Device ID10841522129612
NIH Device Record Key85a5b6b3-a852-4e4d-9d9f-8d3b4a8d03ad
Commercial Distribution StatusIn Commercial Distribution
Brand NameSpacelabs
Version Model NumberABP Cuffs and Cuff Covers
Catalog Number016-0077-07Q
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 Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

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Device Identifiers

Device Issuing AgencyDevice ID
GS110841522129612 [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-06-17
Device Publish Date2024-06-07

On-Brand Devices [Spacelabs]

10841522113093CAPNO MODULE,92517
10841522113086CAPNO POD,92516
10841522108785OPTION, NELLCOR OXIMAX SPO2, REFURBISHED
10841522106279MODULE,EEG/EMG,32MB
10841522125584LEADWIRES,SNAP,60CM,6SET,SAFETY,AHA HOLTER CODE
10841522129629CUFF,ABP,ADULT,XL,38-50CM/15-20IN,NO LTX
10841522129612CUFF,ABP,ADULT,L,32-42CM/13-17IN,NO LTX
10841522129605CUFF,ABP,CHILD,12-20CM/5-8IN,NO LTX
10841522129582CUFF,ABP,ADULT,S,17-26CM/7-10IN,NO LTX
10841522129216SMART ALARM INTERFACE (SAI)

Trademark Results [Spacelabs]

Mark Image

Registration | Serial
Company
Trademark
Application Date
SPACELABS
SPACELABS
97441290 not registered Live/Pending
Merriman, Edward
2022-06-02
SPACELABS
SPACELABS
73480712 1320540 Live/Registered
Spacelabs Inc.
1984-05-17

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