FDA.reportPublic FDA data

TENS/EMS Electrode Procedure Pack

Primary DI
20627825008550
Brand
TENS/EMS Electrode Procedure Pack
Company
Laborie Medical Technologies Corp.
Model
DIS7000
Device description
15 kits of ELE625 (60) and CAB7025 (60)
Published
2026-05-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20627825008550PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2062782500855020627825008550

GMDN Terms#

Term, Definition table
TermDefinition
Electrode conductive skin pad, reusableA noninvasive conductive material designed to facilitate electrical conduction between an external electrode (e.g., transcutaneous electrical stimulation electrode) and the skin surface. It is typically in the form of a gel pad/patch designed to adhere the electrode (not included) to the skin surface. This is a reusable device.

Regulatory Flags#

DUNS number
117783313
Device count
1
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10627825014844T-DOC 5Fr Air-Charged Abdominal Sensor CatheterCAT5752024-12-12
10627825014851T-DOC 5Fr Air-Charged Single Sensor CatheterCAT595P2024-12-12
10627825014868T-DOC 5Fr Air-Charged Single Sensor CatheterCAT595S2024-12-12
00627825014830SOLAR Anorectal Manometry CatheterK1210AC-L-22122025-03-06
00627825014823SOLAR Anorectal Manometry ChargerZM12-AC59-22132025-03-06
10627825014837SOLAR Anorectal Manometry CatheterK1210AC-L-22122025-03-06
08720648846052SOLAR CompactG4-12025-03-06
08720648846069PIM NXT for eSensePIX70002025-02-21
00627825013536e•Sense 7Fr Single Sensor Coudé Bladder CatheterCATEB27C2024-12-12
00627825013543e•Sense 7Fr Dual Sensor Urethral CatheterCATEB372024-12-12
00627825013529e•Sense 7Fr Single Sensor Bladder CatheterCATEB272024-12-12
10627825013533e•Sense 7Fr Single Sensor Coudé Bladder CatheterCATEB27C2024-12-12
10627825013540e•Sense 7Fr Dual Sensor Urethral CatheterCATEB372024-12-12
00627825013550e•Sense 7Fr Dual Sensor Coudé Uretheral CatheterCATEB37C2024-12-12
00627825013567e•Sense 7Fr Abdominal CatheterCATEA172024-12-12
20627825014841T-DOC 5Fr Air-Charged Abdominal Sensor CatheterCAT5752024-12-12
20627825014858T-DOC 5Fr Air-Charged Single Sensor CatheterCAT595P2024-12-12
20627825014865T-DOC 5Fr Air-Charged Single Sensor CatheterCAT595S2024-12-12
00627825014540Urostym EMG Stimulation Cable, Ch 1CAB8962022-11-10
00627825014557Urostym EMG Cable, Ch 2CAB9062022-11-10