Primary Device ID | 00816310022997 |
NIH Device Record Key | 82d8f5a9-7fcc-4c05-a3eb-4b92177407fe |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | FANTABSTIC DANLEE ELECTRODE RESTING TAB (100 PER POUCH) |
Version Model Number | ED3000 |
Company DUNS | 878130871 |
Company Name | DANLEE MEDICAL PRODUCTS, INC |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | MR Conditional |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | true |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | false |
Expiration Date | true |
Donation Id Number | false |
Contains Natural Rubber Latex | true |
Labeled No Natural Rubber Latex | false |
RX Perscription | false |
OTC Over-The-Counter | false |
Storage Environment Temperature | Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00816310022997 [Primary] |
GS1 | 10816310022994 [Package] Package: BOX [5 Units] In Commercial Distribution |
GS1 | 20816310022991 [Package] Contains: 10816310022994 Package: CASE [10 Units] In Commercial Distribution |
DRX | Electrode, Electrocardiograph |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2020-07-01 |
Device Publish Date | 2020-06-23 |
00816310023819 - DANLEE MEDICAL KIT | 2024-11-07 ECG PREP KIT (ZKIT) AMBU R SERIES |
00816310023802 - DANLEE MEDICAL KIT | 2024-10-18 ECG PREP KIT (ZKIT) CONMED |
00816310023796 - DANLEE MEDICAL KIT | 2024-10-17 ECG PREP KIT (ZKIT) CONMED |
00816310023789 - DANLEE MEDICAL KIT | 2024-08-14 ECG PREP KIT (ZKIT) AMBU R SERIES |
00816310023772 - DANLEE MEDICAL KIT | 2024-06-24 ECG PREP KIT (ZKIT) VERMED |
00816310023758 - DANLEE MEDICAL KIT | 2024-02-29 ECG PREP KIT (ZKIT) AMBU R SERIES |
00816310023765 - DANLEE MEDICAL KIT | 2024-02-29 ECG PREP KIT (ZKIT) AMBU R SERIES |
00816310023741 - DANLEE MEDICAL KIT | 2023-12-22 PREP KIT |