FDA.report

Spacelabs Healthcare

Primary DI
10841522124792
Brand
Spacelabs Healthcare
Company
SPACELABS HEALTHCARE (WASHINGTON), INC
Model
TAY
Catalog number
50-0034-04
Device description
4 ELECTRODE EVO RECORDER, PACKED, ITALIAN
Published
2018-08-20
Public version status
Update
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
MWJElectrocardiograph, ambulatory (without analysis)

Product Code Classifications

CodeDeviceSpecialtyClass
MWJElectrocardiograph, Ambulatory (Without Analysis)Cardiovascular2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10841522124792PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1084152212479210841522124792

GMDN Terms

TermDefinition
Electrocardiographic ambulatory recorderAn electrically-powered, noninvasive device designed to be worn by a patient during daily activities for 24-hour recording of the electrocardiographic signals of the heart, for the diagnosis of cardiac disorders (e.g., arrhythmias). The recorded measurements can be downloaded and analysed at a medical facility, typically using a computer with a dedicated software. Otherwise known as a Holter monitor, the device typically incorporates display and controls, and may include surface electrodes, lead wires and accessories intended for attachment/removal (e.g., wipes, adhesive remover).

Storage And Handling

TypeLowHighCondition
Storage Environment Atmospheric Pressure700 millibar1060 millibar
Storage Environment Humidity15 Percent (%) Relative Humidity93 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius60 Degrees Celsius
Storage Environment Temperature-20 Degrees Celsius65 Degrees Celsius

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

Other Devices From This Company

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10841522106712Spacelabs HealthcareDATUM130112182017-01-03
10841522131639Eclipse MiniEclipse Mini98900-UK2025-09-29
10841522131417Spacelabs HealthcarePatient cables & ECG leadwires700-0328-012025-09-03
10841522131424Spacelabs HealthcarePatient cables & ECG leadwires700-0330-012025-09-03
10841522129599SpacelabsABP Cuffs and Cuff Covers015-0068-07Q2025-03-13
10841522130816TrulinkNIBP Hoses and Adapters714-0060-022025-03-13
10841522131431OnTrakOnTrak90227-82025-02-27
10841522100406Spacelabs HealthcareAbsorber122009022016-12-29
10841522100413Spacelabs HealthcareAbsorber122009032016-12-29
10841522100383Spacelabs HealthcareAbsorber122009002016-12-29
10841522100390Spacelabs HealthcareAbsorber122009012016-12-29
10841522100420Spacelabs HealthcareAbsorber122009042016-12-29
10841522100437Spacelabs HealthcareAbsorber122009052016-12-29
10841522131455QubeQube Compact Monitor913902024-12-04
10841522131462qube miniQube Mini913892024-12-04
10841522131479XprezzonXprezzon Monitor913932024-12-04
10841522129216SpacelabsSmart Alarm Interface (SAI)961812024-08-16
30841522126417TrulinkNIBP Hoses and adapters704-00272024-07-16
10841522129773Lifescreen ProLifescreen Pro040-5173-002024-07-16
30841522125618Spacelabs HealthcarePatient cables & ECG leadwires50-00492018-08-10

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
10841522131639Eclipse MiniSPACELABS HEALTHCARE (WASHINGTON), INCMWJ2025-09-29
10841522131417Spacelabs HealthcareSPACELABS HEALTHCARE (WASHINGTON), INCMWJ2025-09-03
10841522131424Spacelabs HealthcareSPACELABS HEALTHCARE (WASHINGTON), INCMWJ2025-09-03
04250903200991SEER 1000getemed Medizin- und Informationstechnik AGMWJ2025-03-14
04250903201011SEER 1000getemed Medizin- und Informationstechnik AGMWJ2025-03-14
04250903201035SEER 1000getemed Medizin- und Informationstechnik AGMWJ2025-03-14
04250903200878SEER 1000getemed Medizin- und Informationstechnik AGMWJ2025-03-04
04250903200892SEER 1000getemed Medizin- und Informationstechnik AGMWJ2025-03-04
04250903200915SEER 1000getemed Medizin- und Informationstechnik AGMWJ2025-03-04
04250903201080SEER 1000getemed Medizin- und Informationstechnik AGMWJ2025-03-04
04250903201103SEER 1000getemed Medizin- und Informationstechnik AGMWJ2025-03-04
04250903201127SEER 1000getemed Medizin- und Informationstechnik AGMWJ2025-03-04
00840241600313ASSURE Wearable ECGKestra Medical Technologies, Inc.MWJ2024-09-18
00840241600320Battery Kestra Medical Technologies, Inc.MWJ2024-09-18
00840241600337System CableKestra Medical Technologies, Inc.MWJ2024-09-18
10841522127274Eclipse ProSPACELABS HEALTHCARE (WASHINGTON), INCMWJ2024-06-07
10841522129698Eclipse ProSPACELABS HEALTHCARE (WASHINGTON), INCMWJ2024-06-07
10841522129728Eclipse ProSPACELABS HEALTHCARE (WASHINGTON), INCMWJ2024-06-07
10841522129742Eclipse ProSPACELABS HEALTHCARE (WASHINGTON), INCMWJ2024-06-07
10841522129810Eclipse ProSPACELABS HEALTHCARE (WASHINGTON), INCMWJ2024-06-07
30841522125557EVOSPACELABS HEALTHCARE (WASHINGTON), INCMWJ2024-04-22
10841522129209Eclipse MiniSPACELABS HEALTHCARE (WASHINGTON), INCMWJ2024-03-19
10841522128769Eclipse MiniSPACELABS HEALTHCARE (WASHINGTON), INCMWJ2024-03-15
B635BIOTRESPR0Biotres ProBIOTRICITY INCMWJ2024-03-07
10841522129674Eclipse ProSPACELABS HEALTHCARE (WASHINGTON), INCMWJ2024-02-28
10841522129704Eclipse ProSPACELABS HEALTHCARE (WASHINGTON), INCMWJ2024-02-28
10841522129711Eclipse ProSPACELABS HEALTHCARE (WASHINGTON), INCMWJ2024-02-28
08800159500022S-Patch ExLWellysis Corp.MWJ2024-02-21
04250903202636SEER 1000getemed Medizin- und Informationstechnik AGMWJ2023-12-01
04250903202643SEER 1000getemed Medizin- und Informationstechnik AGMWJ2023-12-01