FDA.report

Hillrom

Primary DI
50009336009423
Brand
Hillrom
Company
GRAPHIC CONTROLS ACQUISITION CORP
Model
108071
Catalog number
108071
Published
2019-10-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
DRXElectrode, Electrocardiograph

Product Code Classifications

CodeDeviceSpecialtyClass
DRXElectrode, ElectrocardiographCardiovascular2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
30009336009429PackageGS1500In Commercial Distribution
50009336009423PackageGS15000In Commercial Distribution
10009336009425PrimaryGS10
00009336009428Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
3000933600942930009336009429
5000933600942350009336009423
1000933600942510009336009425
00009336009428000093360094280093360094280009336009428

GMDN Terms

TermDefinition
Electrocardiographic electrode, single-useA non-sterile, noninvasive electrical conductor designed to conduct electrical signals, generated by a patient's heart, from the skin surface to an electrocardiograph (ECG) monitoring device, via an ECG lead wire (not included). It is typically a disk-like electrode that is affixed to the skin with a special adhesive, adhesive tape, or suction mechanism; a conductive gel may be pre-applied and it may include a skin cleaning wipe to assist electrical connection. Electrocardiography is usually performed using a set of electrodes (e.g., 10) connected to appropriate leads and cables. This is a single-use device.

Storage And Handling

TypeLowHighCondition
Handling Environment Temperature32 Degrees Fahrenheit90 Degrees Fahrenheit

Sterilization Methods

Method

Contacts

PhoneEmail
1.800.669.6905info@vermed.com

Regulatory Flags

DUNS number
002111896
Device count
100
DM exempt
false
Premarket exempt
true
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
true
Sterilization required before use
false

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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

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