| Primary Device ID | 00819601025745 |
| NIH Device Record Key | b1a454eb-028c-4c67-971a-64ca61011305 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | BVI Medical |
| Version Model Number | ISPAN |
| Catalog Number | SMPQBVI180@1S |
| Company DUNS | 118537769 |
| Company Name | Airgas Therapeutics, LLC |
| 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 | true |
| Serial Number | false |
| Manufacturing Date | true |
| 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 | false |
| Phone | 866-906-8080 |
| customersupport@bvimedical.com | |
| Phone | 866-906-8080 |
| customersupport@bvimedical.com | |
| Phone | 866-906-8080 |
| customersupport@bvimedical.com | |
| Phone | 866-906-8080 |
| customersupport@bvimedical.com | |
| Phone | 866-906-8080 |
| customersupport@bvimedical.com | |
| Phone | 866-906-8080 |
| customersupport@bvimedical.com | |
| Phone | 866-906-8080 |
| customersupport@bvimedical.com | |
| Phone | 866-906-8080 |
| customersupport@bvimedical.com | |
| Phone | 866-906-8080 |
| customersupport@bvimedical.com | |
| Phone | 866-906-8080 |
| customersupport@bvimedical.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00819601025745 [Primary] |
| CAN | Regulator, Pressure, Gas Cylinder |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-06-16 |
| Device Publish Date | 2025-06-06 |
| 10819601025711 | ISPAN Gas, Perfluoropropane (C3F8); Cylinder: LD2; Valve: CGA 165; Retinal tamponade for use in |
| 10819601025704 | ISPAN Gas, Perfluoropropane (C3F8); Cylinder: LD2; Valve: CGA 180; Retinal tamponade for use in |
| 10819601025698 | ISPAN Gas, Perfluoropropane (C3F8); Cylinder: LD1; Valve: CGA 180; Retinal tamponade for use in |
| 10819601025681 | ISPAN Gas, Sulfur Hexafluoride (SF6); Cylinder: LD2; Valve: CGA 170; Retinal tamponade for use i |
| 10819601025674 | ISPAN Gas, Sulfur Hexafluoride (SF6); Cylinder: LD2; Valve: CGA 180; Retinal tamponade for use i |
| 10819601025667 | ISPAN Gas, Sulfur Hexafluoride (SF6); Cylinder: LD1; Valve: CGA 180; Retinal tamponade for use |
| 00819601025752 | ISPAN Dual Stage Regulator; CGA 180; For BVI |
| 00819601025745 | ISPAN Single Stage Regulator; CGA 180; For BVI |