DANLEE MEDICAL KIT

GUDID 00816310023055

ECG PREP KIT (ZKIT) CONMED

DANLEE MEDICAL PRODUCTS, INC

Electrocardiographic long-term ambulatory recording support kit Electrocardiographic long-term ambulatory recording support kit Electrocardiographic long-term ambulatory recording support kit Electrocardiographic long-term ambulatory recording support kit Electrocardiographic long-term ambulatory recording support kit Electrocardiographic long-term ambulatory recording support kit Electrocardiographic long-term ambulatory recording support kit Electrocardiographic long-term ambulatory recording support kit
Primary Device ID00816310023055
NIH Device Record Keye1baedcc-266d-4b22-bfc7-a445ee9dc5ce
Commercial Distribution StatusIn Commercial Distribution
Brand NameDANLEE MEDICAL KIT
Version Model NumberD021R5AB
Company DUNS878130871
Company NameDANLEE MEDICAL PRODUCTS, INC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100816310023055 [Primary]
GS100816310023055 [Primary]
GS100816310023055 [Primary]
GS100816310023055 [Primary]
GS100816310023055 [Primary]
GS100816310023055 [Primary]
GS100816310023055 [Primary]
GS100816310023055 [Primary]

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-11-09
Device Publish Date2020-10-30

On-Brand Devices [DANLEE MEDICAL KIT]

00816310022638ECG PREP KIT (ZKIT)
00816310022621ECG PREP KIT (ZKIT)
00816310022614ECG PREP KIT (ZKIT) MISC
00816310022607ECG PREP KIT (ZKIT) MISC
00816310022591ECG PREP KIT (ZKIT) VERMED
00816310022584ECG PREP KIT (ZKIT) VERMED
00816310022577ECG PREP KIT (ZKIT) CONMED
00816310022560ECG PREP KIT (ZKIT) CONMED
00816310022553ECG PREP KIT (ZKIT)
00816310022546ECG PREP KIT (ZKIT) VERMED
00816310022539ECG PREP KIT (ZKIT)
00816310022522ECG PREP KIT (ZKIT)
00816310022515ECG PREP KIT (ZKIT) VERMED
00816310022508ECG PREP KIT (ZKIT) VERMED
00816310022492ECG PREP KIT (ZKIT) VERMED
00816310022485ECG PREP KIT (ZKIT) CONMED
00816310022478ECG PREP KIT (ZKIT) CONMED
00816310022461ECG PREP KIT (ZKIT) VERMED
00816310022454ECG PREP KIT (ZKIT)
00816310022447ECG PREP KIT (ZKIT) VERMED
00816310022430ECG PREP KIT (ZKIT) VERMED
00816310022423ECG PREP KIT (ZKIT) TAYLOR
00816310022409ECG PREP KIT (ZKIT) VERMED
00816310022393ECG PREP KIT (ZKIT) VERMED
00816310022386ECG PREP KIT (ZKIT) VERMED
00816310022379ECG PREP KIT (ZKIT) CONMED
00816310022362ECG PREP KIT (ZKIT) VERMED
00816310022355ECG PREP KIT (ZKIT) CONMED
00816310022331ECG PREP KIT (ZKIT)
00816310022324ECG PREP KIT (ZKIT)
00816310022317ECG PREP KIT (ZKIT) NIKOMED
00816310022294ECG PREP KIT (ZKIT) 3M
00816310022287ECG PREP KIT (ZKIT) CONMED
00816310022270ECG PREP KIT (ZKIT) CONMED
00816310022263ECG PREP KIT (ZKIT) VERMED
00816310022256ECG PREP KIT (ZKIT) VERMED
00816310022249ECG PREP KIT (ZKIT) VERMED
00816310022232ECG PREP KIT (ZKIT) 3M
00816310022225ECG PREP KIT (ZKIT) MISC
00816310022218ECG PREP KIT (ZKIT) CONMED
00816310022201ECG PREP KIT (ZKIT) COVIDIEN/KENDALL
00816310022195ECG PREP KIT (ZKIT) CONMED
00816310022188ECG PREP KIT (ZKIT) CONMED
00816310022171ECG PREP KIT (ZKIT) CONMED
00816310022164ECG PREP KIT (ZKIT) CONMED
00816310022157ECG PREP KIT (ZKIT) CONMED
00816310022133ECG PREP KIT (ZKIT) CONMED
00816310022126ECG PREP KIT (ZKIT) CONMED
00816310022119ECG PREP KIT (ZKIT) VERMED
00816310022102ECG PREP KIT (ZKIT) VERMED

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.