FDA.reportPublic FDA data

BVI Medical

Primary DI
10819601025681
Brand
BVI Medical
Company
Airgas Therapeutics, LLC
Model
ISPAN
Catalog number
SH MDGLD7CB58
Device description
ISPAN Gas, Sulfur Hexafluoride (SF6); Cylinder: LD2; Valve: CGA 170; Retinal tamponade for use in pneumatic retinopexy.
Published
2025-05-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
LPOGases Used Within Eye To Place Pressure On Detached Retina

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LPOGases Used Within Eye To Place Pressure On Detached RetinaOphthalmic3

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10819601025681PackageGS16In Commercial Distribution
00819601025684PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081960102568110819601025681
00819601025684008196010256848196010256840819601025684

GMDN Terms#

Term, Definition table
TermDefinition
Vitreous/aqueous humour replacement medium, intraoperativeA 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Weight125Gram

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
866-906-8080customersupport@bvimedical.com

Regulatory Flags#

DUNS number
118537769
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03760333380671Ulspira TSULSPIRA TSIN0001022024-01-02
00819601026025Scott Medical ProductsCalibration GasZ02NI98MUDC0062026-04-16
00819601026032Scott Medical ProductsCalibration GasZ02NI99MUDC0322026-04-16
00819601025790Alcon Laboratories Inc.ISPAN80650003262026-02-19
00819601025820GANSHORN INDUSTRIESPULMONARY FUNCTION GASZ04NI61FEDC0022026-03-23
00819601025851MasimoCalibration GasZ03XE75KUD00002025-12-19
00819601025868MasimoCalibration GasZ02NI99K15A00022025-12-19
00819601025875MasimoCalibration GasZ03NI10K15A00002025-12-19
00819601025882MasimoCalibration GasZ04OX51K15A00002025-12-19
00819601025899MasimoCalibration GasZ03NI45K15A00002025-12-19
00819601025905MasimoCalibration GasZ02NI99KUD00012025-12-19
00819601025912MasimoCalibration GasZ02NI99K15A00012025-12-19
00819601025929MasimoCalibration GasZ02NI99K15A0002025-12-19
00819601025936MasimoCalibration GasZ02OX50KUD00002025-12-19
00819601025943MasimoCalibration GasZ02NI98K15A00002025-12-19
00819601025950MasimoCalibration GasZ02OX95K15A00002025-12-19
00819601025967MasimoCalibration GasZ02NI87K15A00002025-12-19
00819601025974MasimoCalibration GasZ02NI70K15A00002025-12-19
00819601025837EscalonISPANSMPQES180@V22025-11-21
00819601025769DIAMOND DIAGNOSTICSCalibration GasZ02NI908QDC0002025-07-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00819601025660BVI Medical Airgas Therapeutics, LLCLPO2025-05-20
00819601025677BVI Medical Airgas Therapeutics, LLCLPO2025-05-20
00819601025684BVI Medical Airgas Therapeutics, LLCLPO2025-05-20
00819601025691BVI Medical Airgas Therapeutics, LLCLPO2025-05-20
00819601025707BVI Medical Airgas Therapeutics, LLCLPO2025-05-20
00819601025714BVI Medical Airgas Therapeutics, LLCLPO2025-05-20
10819601025667BVI Medical Airgas Therapeutics, LLCLPO2025-05-20
10819601025674BVI Medical Airgas Therapeutics, LLCLPO2025-05-20
10819601025698BVI Medical Airgas Therapeutics, LLCLPO2025-05-20
10819601025704BVI Medical Airgas Therapeutics, LLCLPO2025-05-20
10819601025711BVI Medical Airgas Therapeutics, LLCLPO2025-05-20
00380657530663UNIPURE & UNIFEYEAlcon Laboratories, Inc.LPO2024-10-28
00380657530670UNIPURE & UNIFEYEAlcon Laboratories, Inc.LPO2024-10-28
00380657530687UNIPURE & UNIPEXYAlcon Laboratories, Inc.LPO2024-10-28
00380657530694UNIPURE & UNIPEXYAlcon Laboratories, Inc.LPO2024-10-28
10380657530660UNIPURE & UNIFEYEAlcon Laboratories, Inc.LPO2024-10-28
10380657530677UNIPURE & UNIFEYEAlcon Laboratories, Inc.LPO2024-10-28
10380657530684UNIPURE & UNIPEXYAlcon Laboratories, Inc.LPO2024-10-28
10380657530691UNIPURE & UNIPEXYAlcon Laboratories, Inc.LPO2024-10-28
00885556653371R3Smith & Nephew, Inc.LPO2016-07-19
00885556653388R3Smith & Nephew, Inc.LPO2016-07-19
00885556653395R3Smith & Nephew, Inc.LPO2016-07-19
00885556653401R3Smith & Nephew, Inc.LPO2016-07-19
00885556653418R3Smith & Nephew, Inc.LPO2016-07-19
00885556653425R3Smith & Nephew, Inc.LPO2016-07-19
10860113000109ISPAN C3F8 Intraocular GasESCALON MEDICAL CORP.LPO2014-11-05
10860113000116ISPAN SF6 Intraocular GasESCALON MEDICAL CORP.LPO2014-11-05
00380657971046ISPANAlcon Laboratories, Inc.LPO2014-10-07
00380657970018ISPANAlcon Laboratories, Inc.LPO2014-09-24
00380657970025ISPANAlcon Laboratories, Inc.LPO2014-09-24