| Primary Device ID | 03701354402508 |
| NIH Device Record Key | d88647d4-0489-4b73-ae46-8230f139eec1 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Silicone connection set for ultrasound endoscopes PENTAX 70K and J10 series |
| Version Model Number | PW Enew |
| Company DUNS | 262972663 |
| Company Name | PLASMABIOTICS |
| 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 | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | true |
| Length | 34 Centimeter |
| Width | 23 Centimeter |
| Height | 3 Centimeter |
| Length | 34 Centimeter |
| Width | 23 Centimeter |
| Height | 3 Centimeter |
| Length | 34 Centimeter |
| Width | 23 Centimeter |
| Height | 3 Centimeter |
| Length | 34 Centimeter |
| Width | 23 Centimeter |
| Height | 3 Centimeter |
| Length | 34 Centimeter |
| Width | 23 Centimeter |
| Height | 3 Centimeter |
| Length | 34 Centimeter |
| Width | 23 Centimeter |
| Height | 3 Centimeter |
| Length | 34 Centimeter |
| Width | 23 Centimeter |
| Height | 3 Centimeter |
| Length | 34 Centimeter |
| Width | 23 Centimeter |
| Height | 3 Centimeter |
| Length | 34 Centimeter |
| Width | 23 Centimeter |
| Height | 3 Centimeter |
| Length | 34 Centimeter |
| Width | 23 Centimeter |
| Height | 3 Centimeter |
| Length | 34 Centimeter |
| Width | 23 Centimeter |
| Height | 3 Centimeter |
| Length | 34 Centimeter |
| Width | 23 Centimeter |
| Height | 3 Centimeter |
| Length | 34 Centimeter |
| Width | 23 Centimeter |
| Height | 3 Centimeter |
| Length | 34 Centimeter |
| Width | 23 Centimeter |
| Height | 3 Centimeter |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 03701354402508 [Primary] |
| LXG | Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-05-21 |
| Device Publish Date | 2021-05-13 |
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| 03701354404601 - Self-adhesive bar-code, 10 units | 2021-05-24 Self-adhesive bar-code, 10 units |
| 03701354404700 - Coplex bar-code (to attach), 10 units | 2021-05-24 Coplex bar-code (to attach), 10 units |
| 03701354404809 - Stainless steel bar-code (to attach), 10 units | 2021-05-24 Stainless steel bar-code (to attach), 10 units |
| 03701354404908 - Demo Flight case | 2021-05-24 Demo Flight case |
| 03701354405004 - Endoscope surrogate (channel system) and its connection set for demonstration pu | 2021-05-24 Endoscope surrogate (channel system) and its connection set for demonstration purposes |
| 03701354405103 - Silicone connection set for ultrasound bronchoscopes PENTAX EB19-J10U | 2021-05-24 Silicone connection set for ultrasound bronchoscopes PENTAX EB19-J10U |