FDA.report

Vive

Primary DI
10818323027836
Brand
Vive
Company
VIVE HEALTH LLC
Model
RHB1033FBR100
Device description
New Fabric Electrodes (100 Count)
Published
2019-05-01
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
GXYElectrode, Cutaneous

Product Code Classifications

CodeDeviceSpecialtyClass
GXYElectrode, CutaneousNeurology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10818323027836PackageGS124In Commercial Distribution
00818323027839PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1081832302783610818323027836
00818323027839008183230278398183230278390818323027839

GMDN Terms

TermDefinition
External defibrillator electrode, adult, single-useAn electrical conductor used in pairs to transmit a controlled electrical shock from an external defibrillator to a post-pubescent patient in order to defibrillate the heart (restore a normal rhythm) or slow a rapid heart rate. It typically consists of a cable set [with a connector for insertion into the external pulse generator (EPG)] that terminates with self-affixing pads (the electrodes) prefabricated with contact gel and an adhesive, that are applied to the chest (the intact torso) of the patient so that the discharge passes across the region of the heart. This device may remain applied to the patient during stages of treatment. This is a single-use device.

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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00810178886906ViveSUP2019BGES2026-02-17
00810178886913ViveSUP2019BGEM2026-02-17
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00810178886937ViveSUP2019BGEXL2026-02-17
00810178886944ViveSUP2019BLKXS2026-02-17
00810178886951ViveSUP2019BLKS2026-02-17
00810178886968ViveSUP2019BLKM2026-02-17

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