FDA.reportPublic FDA data

HyperView

Primary DI
00869661000251
Brand
HyperView
Company
Hypermed Imaging, Inc.
Model
105-A002
Device description
HyperView Accessories Kit
Published
2017-11-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
MUDOximeter, Tissue Saturation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MUDOximeter, Tissue SaturationCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K161237000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K161237000HyperView Hyperspectral Tissue Oxygenation Measurement SystemHypermed Imaging, Inc.2016-12-16MUD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00869661000251PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00869661000251008696610002518696610002510869661000251

GMDN Terms#

Term, Definition table
TermDefinition
Patient monitoring system module, pulse oximetryA small unit dedicated to the transcutaneous measurement of haemoglobin oxygen saturation (SpO2) in blood using light detection methods (spectrophotometry) after light is emitted from a light-emitting diode (LED) situated in the connected probe. It is designed to operate as part of a patient monitoring system enhancing the function of this system (the parent device). The module automatically plugs into the parent device when the user places it into a standardized slot in the parent device or a connected module rack. The parent device operates as a mainframe computer displaying the pulse oximetry parameters provided by this module.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
034813512
Device count
1
Kit
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00869661000206HyperView101-A0002017-11-23
00869661000213HyperView102-A0012017-11-23
00869661000220HyperView103-A0012017-11-23
00869661000237HyperView105-A0042017-11-23
00869661000244HyperView105-A0052017-11-23

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Primary DI, Brand, Company table
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00690103217971HemoSphere AltaEdwards Lifesciences LLCMUD2025-03-13
10884521845039INVOSCovidien LPMUD2025-02-08
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00690103218848HemoSphere VitaEdwards Lifesciences LLCMUD2024-02-26
00690103218855HemoSphere VitaEdwards Lifesciences LLCMUD2024-02-26
00690103218862HemoSphere VitaEdwards Lifesciences LLCMUD2024-02-26
10884521824409INVOSCovidien LPMUD2023-11-03
10884521824416INVOSCovidien LPMUD2023-11-03