FANTABSTIC DANLEE ELECTRODE RESTING TAB (100 PER POUCH)

GUDID 00816310022997

DANLEE MEDICAL PRODUCTS, INC

Electrocardiographic electrode, single-use
Primary Device ID00816310022997
NIH Device Record Key82d8f5a9-7fcc-4c05-a3eb-4b92177407fe
Commercial Distribution StatusIn Commercial Distribution
Brand NameFANTABSTIC DANLEE ELECTRODE RESTING TAB (100 PER POUCH)
Version Model NumberED3000
Company DUNS878130871
Company NameDANLEE MEDICAL PRODUCTS, INC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latextrue
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100816310022997 [Primary]
GS110816310022994 [Package]
Package: BOX [5 Units]
In Commercial Distribution
GS120816310022991 [Package]
Contains: 10816310022994
Package: CASE [10 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DRXElectrode, Electrocardiograph

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-07-01
Device Publish Date2020-06-23

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