DANLEE MEDICAL KIT

GUDID 00816310023383

ECG PREP KIT (ZKIT) CONMED

DANLEE MEDICAL PRODUCTS, INC

Electrocardiographic long-term ambulatory recording support kit

Primary Device ID	00816310023383
NIH Device Record Key	b7666e6b-3686-4fa0-8fe0-35e84a70704f
Commercial Distribution Status	In Commercial Distribution
Brand Name	DANLEE MEDICAL KIT
Version Model Number	ELE7000
Company DUNS	878130871
Company Name	DANLEE MEDICAL PRODUCTS, INC
Device Count	1
DM Exempt	false
Pre-market Exempt	true
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	true
Device Combination Product	false
Single Use	true
Lot Batch	false
Serial Number	false
Manufacturing Date	false
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	false
OTC Over-The-Counter	false

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816310023383 [Primary]

Sterilization

Steralize Prior To Use	false
Device Is Sterile	false

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2022-04-14
Device Publish Date	2022-04-06

On-Brand Devices [DANLEE MEDICAL KIT]

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