FDA UDI
In Commercial Distribution
🇺🇸 United States
BVI Medical
DI: 00819601025691
·
Model: ISPAN
·
Airgas Therapeutics, LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- BVI Medical
- Primary DI
- 00819601025691
- Version / Model
- ISPAN
- Catalog Number
- 3R MDGLD1CB58
- Company Name
- Airgas Therapeutics, LLC
- Labeler DUNS
- 118537769
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-05-20
- Public Version
- 1
- Public Version Date
- 2025-05-28
- Public Version Status
- New
- Public Device Record Key
- ce8a8757-3563-49f4-a97c-94846283df8e
Device Description
ISPAN Gas, Perfluoropropane (C3F8); Cylinder: LD1; Valve: CGA 180; Retinal tamponade for use in pneumatic retinopexy.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LPO | Gases Used Within Eye To Place Pressure On Detached Retina | Ophthalmic | 886.4270 | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35907 | Vitreous/aqueous humour replacement medium, intraoperative | A nonimplantable artificial fluid, semifluid, or viscoelastic substance intended to be used to replace the vitreous or aqueous humour within the eye to help facilitate the performance of ophthalmic surgery (e.g., to maintain the shape of the eyeball during the intervention, preserve tissue integrity, protect from surgical trauma, and/or to function as a tamponade during retinal reattachment). It may be supplied in a prefilled sterile syringe or other container. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10819601025698 | GS1 | Case | 6 | In Commercial Distribution | |
| Primary | 00819601025691 | GS1 |
Customer Contacts
- Phone
- 866-906-8080
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Weight | 20 | Gram |