FDA.reportPublic FDA data

Escalon

Primary DI
00819601025837
Brand
Escalon
Company
Airgas Therapeutics, LLC
Model
ISPAN
Catalog number
SMPQES180@V2
Device description
ISPAN - CGA 180 Dual Stage Regulator for Escalon
Published
2025-11-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
CANRegulator, Pressure, Gas Cylinder

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CANRegulator, Pressure, Gas CylinderAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00819601025837PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00819601025837008196010258378196010258370819601025837

GMDN Terms#

Term, Definition table
TermDefinition
Intraocular gas cylinder regulatorA reduction valve designed to be attached through a gastight connector (e.g., a pin-index or bull-nosed screw thread connection) to the valve stem of a gas cylinder used to deliver intraocular gas [i.e., sulfur hexafluoride (SF6) or perfluoropropane (C3F8) used as a tamponade for retinal surgery] to lower high, variable gas pressure to a lower, constant working pressure. It can be a single or a dual stage regulator, usually of a piston or diaphragm design. It will have a safety relief valve to avoid excessive pressure due to increased ambient temperatures and usually a manometer or manometers to display the available gas reserve of a gas cylinder and the working pressure.

Regulatory Flags#

DUNS number
118537769
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

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
00819601025769DIAMOND DIAGNOSTICSCalibration GasZ02NI908QDC0002025-07-25
00819601025776DIAMOND DIAGNOSTICSCalibration GasZ03NI835QDC0002025-07-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00628101620387OhioOHIO MEDICAL, LLCCAN2026-05-18
00628101620837OhioOHIO MEDICAL, LLCCAN2026-05-18
00628101620851OhioOHIO MEDICAL, LLCCAN2026-05-18
00628101632625OhioOHIO MEDICAL, LLCCAN2026-05-18
30653405988636Beamer AVEOConmed CorporationCAN2024-12-31
00810050863025MEDPAKLIFEPORT, LLCCAN2024-12-02
G298153187300010NAControl Devices, LLCCAN2024-08-09
G2983429110200B080NAControl Devices, LLCCAN2024-08-09
G2981531871600100NAControl Devices, LLCCAN2024-08-08
G298153187160050NAControl Devices, LLCCAN2024-08-08
G298153187270020NAControl Devices, LLCCAN2024-08-08
G298153187270040NAControl Devices, LLCCAN2024-08-08
G298153187270050NAControl Devices, LLCCAN2024-08-08
G298153187270080NAControl Devices, LLCCAN2024-08-08
G298153187280010NAControl Devices, LLCCAN2024-08-08
G298153187280020NAControl Devices, LLCCAN2024-08-08
G298153187280030NAControl Devices, LLCCAN2024-08-08
G298153187280040NAControl Devices, LLCCAN2024-08-08
G2982108080NAControl Devices, LLCCAN2024-08-08
G2982108150NAControl Devices, LLCCAN2024-08-08
G2982108250NAControl Devices, LLCCAN2024-08-08
G2982212200NAControl Devices, LLCCAN2024-08-08
G2982216200NAControl Devices, LLCCAN2024-08-08
G2982217200NAControl Devices, LLCCAN2024-08-08
G298153187280050NAControl Devices, LLCCAN2024-07-30
G298153187280080NAControl Devices, LLCCAN2024-07-30
G298202230NAControl Devices, LLCCAN2024-07-30
G298153187220010NAControl Devices, LLCCAN2024-07-26
G298153187220020NAControl Devices, LLCCAN2024-07-26
G298153187220040NAControl Devices, LLCCAN2024-07-26