FDA.report

MEDLINE INDUSTRIES, INC.

Primary DI
30888277698134
Brand
MEDLINE INDUSTRIES, INC.
Company
MEDLINE INDUSTRIES, INC.
Model
MDSM611200
Catalog number
MDSM611200
Device description
ELECTRODE, REPOSITIONABLE, SMALL, PEDI
Published
2020-12-09
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
20888277698137PackageGS15In Commercial Distribution
30888277698134PackageGS1100In Commercial Distribution
40888277698131PackageGS11000In Commercial Distribution
10888277698130PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
2088827769813720888277698137
3088827769813430888277698134
4088827769813140888277698131
1088827769813010888277698130

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
Special Storage Condition, Specify00Keep dry. Keep away from sunlight. Protect from freezing, avoid excessive heat.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)633-5463service@medline.com

Regulatory Flags

DUNS number
025460908
Device count
1
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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