FDA.reportPublic FDA data

Spacelabs Healthcare

Primary DI
10841522103322
Brand
Spacelabs Healthcare
Company
SPACELABS HEALTHCARE (WASHINGTON), INC
Model
TAY
Catalog number
N/A
Device description
Evo Holter Recorder, originally Del Mar Reynolds product
Published
2016-11-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
DSHRECORDER, MAGNETIC TAPE, MEDICAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DSHRecorder, Magnetic Tape, MedicalCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10841522103322PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1084152210332210841522103322

GMDN Terms#

Term, Definition table
TermDefinition
Electrocardiographic lead set, reusableA collection of noninvasive devices intended to conduct electrical signals from a patient's heart, via an electrode attached to the surface of the chest/limbs, to an electrocardiograph (ECG) machine or a patient monitoring system. It is designed as an insulated wire(s), which may additionally include a detachable or permanently attached electrode and/or cable with connector. Some types may be designed as a pre-configured array (e.g., EEG belt) to assist electrode placement. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity0 Percent (%) Relative Humidity0 Percent (%) Relative Humidity
Storage Environment Temperature0 Degrees Celsius0 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
145581588
Device count
1
DM exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10841522100406Spacelabs HealthcareAbsorber122009022016-12-29
10841522100413Spacelabs HealthcareAbsorber122009032016-12-29
10841522128769Eclipse MiniEclipse Mini989002024-03-15
10841522128851Eclipse ProEclipse Pro987002023-10-09
10841522130298Eclipse ProEclipse Pro712-1052-012023-02-23
10841522123122TrulinkAdapter Cables700-0290-002017-09-25
10841522128790SPACELABS HEALTHCARE9022790227-182023-05-25
10841522105067UltraliteUltralite90217A-12016-10-21
10841522126857SPACELABS HEALTHCAREUltralite90217A-22019-02-28
10841522123177ABP9022790227-12017-09-15
10841522126864SPACELABS HEALTHCARE9022790227-22019-02-28
10841522131417Spacelabs HealthcarePatient cables & ECG leadwires700-0328-012025-09-03
10841522131424Spacelabs HealthcarePatient cables & ECG leadwires700-0330-012025-09-03
10841522125478Spacelabs HealthcarePatient cables & ECG leadwires50-00492018-08-10
10841522131479XprezzonXprezzon Monitor913932024-12-04
10841522131455QubeQube Compact Monitor913902024-12-04
10841522106439Ultraview SLUltraview SL®91496-U2016-10-07
10841522103292Spacelabs Healthcare98400N/A2016-09-23
10841522125102PathfinderSLPathfinder SL040-1757-002018-06-19
10841522100208Spacelabs Healthcare90499904992016-10-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
P00020eWave Electrode PatchWearlinq, Inc.DSH2026-07-14
00884838132337Care AssistPhilips Medizin Systeme Böblingen GmbHDSH2026-07-13
00884838132344Care AssistPhilips Medizin Systeme Böblingen GmbHDSH2026-07-13
04250413403578Cuff ABPMpro without ECGSOMNOmedics AGDSH2026-07-07
04250413403585Cuff ABPMpro without ECGSOMNOmedics AGDSH2026-07-07
04250413406456Cuff ABPMpro for right armSOMNOmedics AGDSH2026-07-07
04250413406463Cuff ABPMpro for right armSOMNOmedics AGDSH2026-07-07
04250413406470ABPMpro cuff for right armSOMNOmedics AGDSH2026-07-07
08883000003064AeviceMDAEVICE HEALTH PTE. LTD.DSH2026-06-22
08883000007413AeviceMDAEVICE HEALTH PTE. LTD.DSH2026-05-18
00857522005125myPatch®DMS-SERVICE LLCDSH2026-05-06
00884838129238Care AssistPhilips Medizin Systeme Böblingen GmbHDSH2026-04-17
00884838129245Care AssistPhilips Medizin Systeme Böblingen GmbHDSH2026-04-17
K00010eWave 6-Lead EKGWearlinq, Inc.DSH2026-04-02
P00010eWave Electrode PatchWearlinq, Inc.DSH2026-04-02
00884838129214Care AssistPhilips Medizin Systeme Böblingen GmbHDSH2026-03-09
00884838129221Care AssistPhilips Medizin Systeme Böblingen GmbHDSH2026-03-09
17540279200027CardioSTATIcentia Inc.DSH2025-12-08
00884838127456Care AssistPhilips Medizin Systeme Böblingen GmbHDSH2025-11-17
00884838127463Care AssistPhilips Medizin Systeme Böblingen GmbHDSH2025-11-17
08800069700260AT-PatchATsens Co., Ltd.DSH2025-11-05
08800069700277AT-PatchATsens Co., Ltd.DSH2025-11-05
00884838127432Care AssistPhilips Medizin Systeme Böblingen GmbHDSH2025-05-06
00884838127449Care AssistPhilips Medizin Systeme Böblingen GmbHDSH2025-05-06
27540279250029CardioSTATIcentia Inc.DSH2024-12-18
27540279250074CardioSTATIcentia Inc.DSH2024-12-18
27540279250142CardioSTATIcentia Inc.DSH2024-12-18
00884838123717Care AssistPhilips Medical Systems HsgDSH2024-11-27
00884838123724Care AssistPhilips Medical Systems HsgDSH2024-11-27
00860007323409Vitals360Vocare, Inc.DSH2024-09-10