| Primary Device ID | 00816310022355 | 
| NIH Device Record Key | 6d4ce458-c41c-446b-a8ae-b7db9363810d | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | DANLEE MEDICAL KIT | 
| Version Model Number | COLS022HH5ABVW | 
| 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 Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity | 
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity | 
| Device Issuing Agency | Device ID | 
|---|---|
| GS1 | 00816310022355 [Primary] | 
| Steralize Prior To Use | false | 
| Device Is Sterile | false | 
| Public Version Status | Update | 
| Device Record Status | Published | 
| Public Version Number | 2 | 
| Public Version Date | 2018-03-29 | 
| Device Publish Date | 2017-12-13 | 
| 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 |