| Primary Device ID | 35060842920146 | 
| NIH Device Record Key | 7e7712a5-b1b9-475b-a0d5-02d8263e1bde | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | Dräger | 
| Version Model Number | FW50DR | 
| Catalog Number | 700001872 | 
| Company DUNS | 671405566 | 
| Company Name | NISSHA MEDICAL TECHNOLOGIES LTD | 
| Device Count | 50 | 
| DM Exempt | false | 
| Pre-market Exempt | true | 
| MRI Safety Status | Labeling does not contain MRI Safety Information | 
| Human Cell/Tissue Product | false | 
| Device Kit | false | 
| Device Combination Product | false | 
| Single Use | true | 
| Lot Batch | true | 
| Serial Number | false | 
| Manufacturing Date | true | 
| Expiration Date | true | 
| Donation Id Number | false | 
| Contains Natural Rubber Latex | false | 
| Labeled No Natural Rubber Latex | true | 
| RX Perscription | false | 
| OTC Over-The-Counter | false | 
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of sunlight | 
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of sunlight | 
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of sunlight | 
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of sunlight | 
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of sunlight | 
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of sunlight | 
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of sunlight | 
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of sunlight | 
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of sunlight | 
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of sunlight | 
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of sunlight | 
| Device Issuing Agency | Device ID | 
|---|---|
| GS1 | 05060842920145 [Unit of Use] | 
| GS1 | 15060842920142 [Primary] | 
| GS1 | 35060842920146 [Package] Contains: 15060842920142 Package: Inner Box [400 Units] In Commercial Distribution | 
| GS1 | 55060842920140 [Package] Package: Shipper Carton [4800 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 | 2024-03-11 | 
| Device Publish Date | 2024-03-01 | 
| 35060842920153 | ECG Electrode | 
| 35060842920146 | ECG Electrode | 
| Mark Image Registration | Serial | Company Trademark Application Date | 
|---|---|
|  DRAGER  73623646  1582085 Live/Registered | DRAGERWERK AG 1986-10-02 |