FDA.report

Spacelabs Healthcare

Primary DI
10841522106910
Brand
Spacelabs Healthcare
Company
SPACELABS HEALTHCARE (WASHINGTON), INC
Model
CCONNECT
Catalog number
CCT
Device description
CARDIOCONNECT KIT
Published
2018-08-07
Public version status
Update
Distribution status
Not 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
DXHTRANSMITTERS AND RECEIVERS, ELECTROCARDIOGRAPH, TELEPHONE

Product Code Classifications

CodeDeviceSpecialtyClass
DXHTransmitters And Receivers, Electrocardiograph, TelephoneCardiovascular2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10841522106910PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1084152210691010841522106910

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).

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
true
Sterilization required before use
false

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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
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04719872981534QT ECGQt Medical, Inc.DXH2024-07-08
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00856298006435EZLink-CSCOTTCARE CORPORATION, THEDXH2024-05-23
07290008960267RIVER- 1 ELECTROCARDIOGRAPH (ECG) RECORDER AND TRANSMITTERSHL TELEMEDICINE INTERNATIONAL LTD.DXH2023-08-22
07290008960250CardioSen'CSHL TELEMEDICINE INTERNATIONAL LTD.DXH2023-08-21
04719872981510QT ECGQt Medical, Inc.DXH2023-06-08
04719872980896QT ECGQt Medical, Inc.DXH2022-12-19
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04719872980414QT ECGQT MEDICAL, INC.DXH2020-09-21
00868282000220RhythmStarRHYTHMEDIX, LLCDXH2020-09-08
00860000272407Rhythm ExpressVIVAQUANT, INC.DXH2020-07-27
B146ECAT2010ECAT2 GenericBRAEMAR MANUFACTURING, LLCDXH2020-07-15
00860003939703AfibAlertLOHMAN TECHNOLOGIES, LLCDXH2020-07-01
B210AC0190KardiaMobile 6LALIVECOR, INC.DXH2020-05-01
04719872980421QT ECGQT MEDICAL, INC.DXH2019-12-31
06430035220366Bittium FarosMega Elektroniikka OyDXH2019-10-23