AccessGUDID - DEVICE: BVI Medical (00819601025714)

GUDID

Device Identifier (DI) Information

Brand Name: BVI Medical
Version or Model: ISPAN
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 3R MDGLD6CB58
Company Name: Airgas Therapeutics, LLC

Primary DI Number: 00819601025714
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 118537769 *Terms of Use

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

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LPO	Gases Used Within Eye To Place Pressure On Detached Retina

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Weight: 125 Gram

Device Record Status

Public Device Record Key: ce593326-cc3e-4982-9058-a5b05ceb3ca4
Public Version Date: May 28, 2025
Public Version Number: 1
DI Record Publish Date: May 20, 2025