BVI Medical 3R MDGLD6CB58

GUDID 10819601025711

ISPAN Gas, Perfluoropropane (C3F8); Cylinder: LD2; Valve: CGA 165; Retinal tamponade for use in pneumatic retinopexy.

Airgas Therapeutics, LLC

Vitreous/aqueous humour replacement medium, intraoperative
Primary Device ID10819601025711
NIH Device Record Keyce593326-cc3e-4982-9058-a5b05ceb3ca4
Commercial Distribution StatusIn Commercial Distribution
Brand NameBVI Medical
Version Model NumberISPAN
Catalog Number3R MDGLD6CB58
Company DUNS118537769
Company NameAirgas Therapeutics, LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone866-906-8080
Emailcustomersupport@bvimedical.com
Phone866-906-8080
Emailcustomersupport@bvimedical.com
Phone866-906-8080
Emailcustomersupport@bvimedical.com
Phone866-906-8080
Emailcustomersupport@bvimedical.com
Phone866-906-8080
Emailcustomersupport@bvimedical.com
Phone866-906-8080
Emailcustomersupport@bvimedical.com
Phone866-906-8080
Emailcustomersupport@bvimedical.com
Phone866-906-8080
Emailcustomersupport@bvimedical.com
Phone866-906-8080
Emailcustomersupport@bvimedical.com
Phone866-906-8080
Emailcustomersupport@bvimedical.com
Phone866-906-8080
Emailcustomersupport@bvimedical.com
Phone866-906-8080
Emailcustomersupport@bvimedical.com
Phone866-906-8080
Emailcustomersupport@bvimedical.com
Phone866-906-8080
Emailcustomersupport@bvimedical.com
Phone866-906-8080
Emailcustomersupport@bvimedical.com
Phone866-906-8080
Emailcustomersupport@bvimedical.com

Device Dimensions

Weight125 Gram
Weight125 Gram
Weight125 Gram
Weight125 Gram
Weight125 Gram
Weight125 Gram
Weight125 Gram
Weight125 Gram
Weight125 Gram
Weight125 Gram
Weight125 Gram
Weight125 Gram
Weight125 Gram
Weight125 Gram
Weight125 Gram
Weight125 Gram

Device Identifiers

Device Issuing AgencyDevice ID
GS100819601025714 [Primary]
GS110819601025711 [Package]
Contains: 00819601025714
Package: Case [6 Units]
In Commercial Distribution

FDA Product Code

LPOGases Used Within Eye To Place Pressure On Detached Retina

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-05-28
Device Publish Date2025-05-20

On-Brand Devices [BVI Medical ]

10819601025711ISPAN Gas, Perfluoropropane (C3F8); Cylinder: LD2; Valve: CGA 165; Retinal tamponade for use in
10819601025704ISPAN Gas, Perfluoropropane (C3F8); Cylinder: LD2; Valve: CGA 180; Retinal tamponade for use in
10819601025698ISPAN Gas, Perfluoropropane (C3F8); Cylinder: LD1; Valve: CGA 180; Retinal tamponade for use in
10819601025681ISPAN Gas, Sulfur Hexafluoride (SF6); Cylinder: LD2; Valve: CGA 170; Retinal tamponade for use i
10819601025674ISPAN Gas, Sulfur Hexafluoride (SF6); Cylinder: LD2; Valve: CGA 180; Retinal tamponade for use i
10819601025667ISPAN Gas, Sulfur Hexafluoride (SF6); Cylinder: LD1; Valve: CGA 180; Retinal tamponade for use
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.