FDA.report

Eswallow

Primary DI
01092237619451
Brand
Eswallow
Company
COMPASS HEALTH BRANDS CORP.
Model
ESW-9050
Device description
eSwallow
Published
2016-12-31
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

Contact Domains

Product Codes

CodeName
GXYElectrode, Cutaneous

Product Code Classifications

CodeDeviceSpecialtyClass
GXYElectrode, CutaneousNeurology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
01092237619451Direct MarkingGS10
30092237619453PackageGS150Not in Commercial Distribution
80092237619458PackageGS14Not in Commercial Distribution
00092237618271PreviousGS10
00009223761941PrimaryGS10
01092237619450Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
01092237619451010922376194511092237619451
3009223761945330092237619453
8009223761945880092237619458
00092237618271000922376182710922376182710092237618271
00009223761941000092237619410092237619410009223761941
01092237619450010922376194501092237619450

GMDN Terms

TermDefinition
Transcutaneous electrical stimulation electrode, single-useAn electrical conductor intended to be attached to a patient's skin (noninvasive) to provide therapeutic electrical stimuli through the body surface [e.g., transcutaneous electrical nerve stimulation (TENS), electrical muscle stimulation (EMS), cranial electrotherapy stimulation (CES)]. It is typically a flat, flexible, conductive pad with an adhesive (e.g., gel), or a preformed shape/mechanism designed for attachment to a particular body part (e.g., earclip), connected to a conductive wire. This is a single-use device.

Sterilization Methods

Method

Contacts

PhoneEmail
440-572-1962CustomerService@compasshealthbrands.com
800-376-7263customerservice@compasshealthbrands.com

Regulatory Flags

DUNS number
827221698
Device count
2
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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