| Primary Device ID | 00816310023055 |
| NIH Device Record Key | e1baedcc-266d-4b22-bfc7-a445ee9dc5ce |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | DANLEE MEDICAL KIT |
| Version Model Number | D021R5AB |
| 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 |
| 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 Issuing Agency | Device ID |
|---|---|
| GS1 | 00816310023055 [Primary] |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-11-09 |
| Device Publish Date | 2020-10-30 |
| 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 |