PAD 3020-ZMI

Primary DI
00811331018103
Brand
PAD 3020-ZMI
Company
Tz Medical, Inc.
Model
PAD 3020-ZMI
Device description
ADAPTER- TEST SINGLE PC DUAL
Published
2023-09-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
DROPacemaker, Cardiac, External Transcutaneous (Non-Invasive)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DROPacemaker, Cardiac, External Transcutaneous (Non-Invasive)Cardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K983196000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K983196000PADTAK PACE/DEFIB/CARDIOVERT MONITORING ELECTRODE(S)Tz Medical, Inc.1999-09-15DRO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00811331018103PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00811331018103008113310181038113310181030811331018103

GMDN Terms#

Term, Definition table
TermDefinition
External defibrillation electrode, adult, reusableAn electrical conductor intended to be 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 usually consists of a cable set that terminates with electrodes (paddles) that are hand-held by the operator to the chest (the intact torso) or back of the patient so that the discharge passes across the region of the heart. Typically available as a set of two electrodes with a combined cable/connector, or as a single electrode with cable/connector, in which case two will be connected to the external pulse generator (EPG). This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
793149709
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
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00811331011227EZ HolderCT-00102023-10-20
00811331011340ARC Adjustable Radial CuffRCB-00482023-11-15
00811331011487ARC Adjustable Radial CuffRCB-00492023-11-15
00811331011500ARC Adjustable Radial CuffRCB-00472023-11-15
00811331011470ARC Adjustable Radial CuffRCB-00492023-11-15
00811331011333ARC Adjustable Radial CuffRCB-00472023-11-15
00811331013917H3R USB CableH3R-00252023-11-15
00811331013931H3R HolsterH3R-00272023-11-15
10811331010173Comfort BandCB-8514B2023-10-20
10811331010180Comfort BandCB-8517P2023-10-20
10811331010487TZ Medical Pressure Discs8880-042023-10-20
10811331013259TZ Medical Pressure Discs8880-032023-10-20
00811331010053TZ Medical Pressure Discs8880-022023-10-20
00811331011654TruBrite Adhesive Retractor LightARL-10102023-10-20
00811331011722TZ Medical Pressure Discs8880-012023-10-20
00811331011845TZ Medical Pressure Discs8880-062023-10-20
00811331013245TZ Medical Pressure Discs8880-022023-10-20
00811331011210EZ HolderCT-00102023-10-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10811331010302Defibrillation ElectrodesTz Medical, Inc.DRO2020-12-30
10811331010319Defibrillation ElectrodesTz Medical, Inc.DRO2020-12-30
10811331010326Defibrillation ElectrodesTz Medical, Inc.DRO2020-12-30
10811331010333Defibrillation ElectrodesTz Medical, Inc.DRO2020-12-30
10811331010340Defibrillation ElectrodesTz Medical, Inc.DRO2020-12-30
10811331010357Defibrillation ElectrodesTz Medical, Inc.DRO2020-12-30
10811331010364Defibrillation ElectrodesTz Medical, Inc.DRO2020-12-30
10811331010371Defibrillation ElectrodesTz Medical, Inc.DRO2020-12-30
10811331010388Defibrillation ElectrodesTz Medical, Inc.DRO2020-12-30
10811331010395Defibrillation ElectrodesTz Medical, Inc.DRO2020-12-30
10811331010401Defibrillation ElectrodesTz Medical, Inc.DRO2020-12-30
10811331010418Defibrillation ElectrodesTz Medical, Inc.DRO2020-12-30
10811331010425Defibrillation ElectrodesTz Medical, Inc.DRO2020-12-30
10811331010432Defibrillation ElectrodesTz Medical, Inc.DRO2020-12-30
10811331010449Defibrillation ElectrodesTz Medical, Inc.DRO2020-12-30
10811331010456Defibrillation ElectrodesTz Medical, Inc.DRO2020-12-30
10811331010463Defibrillation ElectrodesTz Medical, Inc.DRO2020-12-30
10811331010647Defibrillation ElectrodesTz Medical, Inc.DRO2020-12-30
10811331010654Defibrillation ElectrodesTz Medical, Inc.DRO2020-12-30
10811331010661Defibrillation ElectrodesTz Medical, Inc.DRO2020-12-30
10811331010678Defibrillation ElectrodesTz Medical, Inc.DRO2020-12-30
10811331010685Defibrillation ElectrodesTz Medical, Inc.DRO2020-12-30
10811331010692Defibrillation ElectrodesTz Medical, Inc.DRO2020-12-30
00811331010565Defibrillation ElectrodesTz Medical, Inc.DRO2020-12-30
00811331010596Defibrillation ElectrodesTz Medical, Inc.DRO2020-12-30
00811331010619Defibrillation ElectrodesTz Medical, Inc.DRO2020-12-30
00811331011098Defibrillation ElectrodesTz Medical, Inc.DRO2020-12-30
00811331011111Defibrillation ElectrodesTz Medical, Inc.DRO2020-12-30
00811331011135Defibrillation ElectrodesTz Medical, Inc.DRO2020-12-30
00811331011425Defibrillation ElectrodesTz Medical, Inc.DRO2020-12-30