Spacelabs 19-7509

GUDID 10841522125584

LEADWIRES,SNAP,60CM,6SET,SAFETY,AHA HOLTER CODE

SPACELABS HEALTHCARE (WASHINGTON), INC

Electrical-only medical device connection cable, reusable
Primary Device ID10841522125584
NIH Device Record Key1e133649-9b4f-438d-957c-3c3e13a7598b
Commercial Distribution StatusIn Commercial Distribution
Brand NameSpacelabs
Version Model NumberPatient cables & ECG leadwires
Catalog Number19-7509
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 Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Dimensions

Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS110841522125584 [Primary]

FDA Product Code

MWJElectrocardiograph, ambulatory (without analysis)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2023-10-23
Device Publish Date2018-08-29

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

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.