Lifescreen Pro 040-5173-00

GUDID 10841522129773

SENTINEL/LIFESCREEN PRO RAPID ANALYSIS KIT EN

SPACELABS HEALTHCARE (WASHINGTON), INC

Cardiology information system application software
Primary Device ID10841522129773
NIH Device Record Key24e9ad10-4d95-400d-89fa-689afb8ad7ac
Commercial Distribution StatusIn Commercial Distribution
Brand NameLifescreen Pro
Version Model NumberLifescreen Pro
Catalog Number040-5173-00
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 Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS110841522129773 [Primary]

FDA Product Code

DQKComputer, diagnostic, programmable

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-07-24
Device Publish Date2024-07-16

Devices Manufactured by SPACELABS HEALTHCARE (WASHINGTON), INC

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10841522100390 - Spacelabs Healthcare2025-02-11 ABSORBER, BYPASS, 1KG (RE-ROUTE)
10841522100420 - Spacelabs Healthcare2025-02-11 ABSORBER, BYPASS, 2KG (RE-ROUTE) MRI
10841522100437 - Spacelabs Healthcare2025-02-11 ABSORBER, BYPASS, 1KG (RE-ROUTE) MRI
10841522131455 - Qube2024-12-12 COMPACT MONITOR,91390
10841522131462 - qube mini2024-12-12 QUBE MINI TRANSPORT MONITOR
10841522131479 - Xprezzon2024-12-12 XPREZZON MONITOR,91393
10841522129216 - Spacelabs2024-08-26 SMART ALARM INTERFACE (SAI)
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