FDA.report

VIVE

Primary DI
10810041980035
Brand
VIVE
Company
VIVE HEALTH LLC
Model
DMD1046
Device description
Bluetooth Pulse Oximeter
Published
2019-12-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
OCHOximeter, Infrared, Sporting, Aviation
PGJOximeter, Wellness

Product Code Classifications

CodeDeviceSpecialtyClass
OCHOximeter, Infrared, Sporting, AviationCardiovascular2
PGJOximeter, WellnessCardiovascular2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10810041980035PackageGS11In Commercial Distribution
00810041980038PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1081004198003510810041980035
00810041980038008100419800388100419800380810041980038

GMDN Terms

TermDefinition
Telemetric pulse oximeterA portable, photoelectric device intended for the transcutaneous monitoring of haemoglobin oxygen saturation (SpO2) through the radio transmission/reception of SpO2 values. The signals, typically produced by light-emitting diodes (LEDs) and a receiving detector in a probe, or directly built-in, are used to make the measurements using the principle of spectrophotometry. The oximeter displays the SpO2 values and may calculate/display other parameters, e.g., pulse rate, electrocardiogram (ECG) which are radio transmitted to a monitoring site to obviate the need for cabling, promoting the patient's freedom of movement.

Sterilization Methods

Method

Regulatory Flags

DUNS number
047025993
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
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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00810178884643ViveMOB1142BLK2026-03-06
00810178884766ViveMOB1144GRY2026-03-06
00810178884773ViveMOB1144BLU2026-03-06
00810178884780ViveMOB1144PNK2026-03-06
00810178885213ViveMOB1139BLK262026-03-06
00810178885220ViveMOB1139BLK282026-03-06
00810178885237ViveMOB1139BLK302026-03-06
00810178887040ViveLVA1004DBLU2026-03-06
00810178887057ViveLVA2030DBLU2026-03-06
00810178887392Vive MobilityMOB1079GRY2026-02-18
00810178886890ViveSUP2019BGEXS2026-02-17
00810178886906ViveSUP2019BGES2026-02-17
00810178886913ViveSUP2019BGEM2026-02-17
00810178886920ViveSUP2019BGEL2026-02-17
00810178886937ViveSUP2019BGEXL2026-02-17
00810178886944ViveSUP2019BLKXS2026-02-17
00810178886951ViveSUP2019BLKS2026-02-17
00810178886968ViveSUP2019BLKM2026-02-17

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