Vermed Holter Kit

Primary DI
00813150022477
Brand
Vermed Holter Kit
Company
GRAPHIC CONTROLS ACQUISITION CORP
Model
KIT-HOL2
Catalog number
KIT-HOL2
Device description
Packed for: Holter Labs Cardiac Monitoring 1-888-821-4667 50 KITS PER CASE
Published
2017-04-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00813150022477PrimaryGS10
10813150022474Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00813150022477008131500224778131500224770813150022477
1081315002247410813150022474

GMDN Terms#

Term, Definition table
TermDefinition
Electrocardiographic long-term ambulatory recording support kitA collection of non-sterile, noninvasive devices intended to be used in conjunction with an electrocardiographic (ECG) long-term ambulatory recorder (holter monitor) to facilitate recording. It includes an ECG electrode(s), batteries (to power the recorder), devices intended to assist electrode application (e.g., razor, electrode placement guide, conductive gel, skin cleaning wipe, tape), and may include other patient-supportive devices (e.g., diary/notebook); the recorder is not included. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1.800.669.6905customerservice@vermed.com

Regulatory Flags#

DUNS number
002111896
Device count
50
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
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
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
30009336010593Nissha Medical TechnologiesO-4227-604010453C2026-02-26
30009336010609Nissha Medical TechnologiesO-5235-604010425C2026-02-26
03700506307067BardBardIPC730412019-08-30
03700506307081BiosenseCARTO3IPC730802019-08-30
03700506307098Physio ControlLifepackIPC735112019-08-30
03700506307104St Jude MedicalSt Jude MedicalIPC737452019-08-30
00009336010332SilverRest Resting ECG TAB ElectrodeA100246500045V2024-11-14
00009336002559VermedLWG-6090029/3ALWG-6090029/3A2016-09-24
00009336002573VermedLWG-3090029/3ALWG-3090029/3A2016-09-24
00009336002597VermedLWG-3090029/5ALWG-3090029/5A2017-05-02
00009336002603VermedLWG-2090029GR LWG-2090029GR 2016-09-24
00009336002610VermedLWG-2090029RDLWG-2090029RD2016-09-24
00009336002627VermedLWG-2090029WH LWG-2090029WH 2016-09-24
00009336002665VermedLWG-2090029/3A LWG-2090029/3A 2016-09-24
00009336002672VermedLWG-2090029/5ALWG-2090029/5A2016-09-24
00009336002689VermedLWG-2090029BK LWG-2090029BK 2016-09-24
00009336002696VermedLWG-2090029BR LWG-2090029BR 2016-09-24
00009336002795VermedLWG-3300051/5ALWG-3300051/5A2016-09-24
00009336002863VermedLWG-3300029/5ALWG-3300029/5A2016-09-24
00009336002870VermedLWG-3300029/5AT LWG-3300029/5AT 2016-09-24