FDA.report

SENTINEL / PATHFINDER SL

Primary DI
10841522129346
Brand
SENTINEL / PATHFINDER SL
Company
SPACELABS HEALTHCARE (WASHINGTON), INC
Model
98200; 98000
Catalog number
040-1750-01
Device description
SENTINEL 11 / PATHFINDER SL KIT ES
Published
2021-05-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
DQKComputer, diagnostic, programmable

Product Code Classifications

CodeDeviceSpecialtyClass
DQKComputer, Diagnostic, ProgrammableCardiovascular2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10841522129346PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1084152212934610841522129346

GMDN Terms

TermDefinition
Cardiology information system application softwareAn application software program, routines, and/or algorithms intended to be used as or in an information system to electronically receive, collect, store, manage, assist in analysis of, display, output, and distribute data, within or between healthcare facilities, to support the administrative and clinical activities associated with the provision and utilization of cardiology services and facilities. It is typically supplied for installation into a dedicated information system for cardiology or existing mainframe or decentralized computers/networks.

Sterilization Methods

Method

Regulatory Flags

DUNS number
145581588
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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