| Primary Device ID | 35051223004128 | 
| NIH Device Record Key | e79462c8-f681-445c-ba37-6d5f0b4a118e | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | Insufflation filter / tubing set with 22mm filter | 
| Version Model Number | PS3605 | 
| Catalog Number | PS3605 | 
| Company DUNS | 239403863 | 
| Company Name | PURPLE SURGICAL INTERNATIONAL LIMITED | 
| 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 | true | 
| Lot Batch | true | 
| 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 | true | 
| OTC Over-The-Counter | false | 
| Phone | +441923839333 | 
| mail@purplesurgical.com | 
| Device Issuing Agency | Device ID | 
|---|---|
| GS1 | 05051223004127 [Primary] | 
| GS1 | 35051223004128 [Package] Contains: 05051223004127 Package: shipping carton [25 Units] In Commercial Distribution  | 
| NKC | Tubing/Tubing With Filter, Insufflation, Laparoscopic | 
| Steralize Prior To Use | false | 
| Device Is Sterile | true | 
| Public Version Status | Update | 
| Device Record Status | Published | 
| Public Version Number | 2 | 
| Public Version Date | 2018-03-29 | 
| Device Publish Date | 2016-09-17 | 
| 55051223000612 - Hasson Trocar | 2020-01-09 The Hasson Trocar is designed to provide a port of entry into the abdominal cavity during laparoscopic & endoscopic procedures. | 
| 55051223000629 - Hasson Trocar | 2020-01-09 The Hasson Trocar is designed to provide a port of entry into the abdominal cavity during laparoscopic & endoscopic procedures. | 
| 55051223000636 - Secondary Trocar with gas port | 2020-01-09 The Secondary Trocar is used during laparoscopic procedures to create a secondary port of entry into the abdominal cavity for us | 
| 55051223000704 - Auto-shield trocar, ribbed cannula | 2020-01-09 The AutoShield Trocar is designed to provide a port of entry into the abdominal cavity during laparoscopic & endoscopic procedur | 
| 35051223000717 - Auto-shield trocar, ribbed cannula | 2020-01-09 The AutoShield Trocar is designed to provide a port of entry into the abdominal cavity during laparoscopic & endoscopic procedur | 
| 50551223000742 - Auto-shield trocar, ribbed cannula | 2020-01-09 The AutoShield Trocar is designed to provide a port of entry into the abdominal cavity during laparoscopic & endoscopic procedur | 
| 35051223003374 - Auto Shield Trocar Ribbed, plus extra cannula | 2020-01-09 The AutoShield Trocar is designed to provide a port of entry into the abdominal cavity during laparoscopic & endoscopic procedur | 
| 50551223003873 - Secondary Trocar with gas port | 2020-01-09 The Secondary Trocar is used during laparoscopic procedures to create a secondary port of entry into the abdominal cavity for us |