FDA.reportPublic FDA data

SIS Adaptor

Primary DI
00857136004170
Brand
SIS Adaptor
Company
SUREFIRE MEDICAL, INC.
Model
STA-0001
Device description
Surefire Infusion System Adaptor
Published
2018-02-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
FOXStand, Infusion

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FOXStand, InfusionGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00857136004170PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00857136004170008571360041708571360041700857136004170

GMDN Terms#

Term, Definition table
TermDefinition
Frame/rail/pole device holderA clamp-like device intended to be affixed to a bed frame, standard rail or standing pole [e.g., intravenous (IV) pole] to provide a means to fix/mount a medical device (e.g., suction/irrigation pump, display monitor), or other non-medical device, to the support. It typically has a gripping profile that is compatible with the device it is intended to fit. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
832575497
Device count
1
Premarket exempt
true
Lot or batch
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00857136004293TriNav Advance Infusion SystemADV-38150-352026-09-24
00857136004392TriNav Advance Infusion SystemADV-38115-352026-09-24
00857136004408TriNav Advance Infusion SystemADV-38095-502026-09-24
00857136004415TriNav Advance Infusion SystemADV-38095-352026-09-24
00857136004330TriGuide Guiding CatheterTGC-58065-Axis2025-11-26
00857136004347TriGuide Guiding CatheterTGC-58065-Sim12025-11-26
00857136004354TriGuide Guiding CatheterTGC-58065-Cobra2025-11-26
00857136004248TriGuide Guiding CatheterTGC-48065-Axis2024-08-09
00857136004255TriGuide Guiding CatheterTGC-48065-Sim12024-08-09
00857136004262TriGuide Guiding CatheterTGC-48065-Cobra2024-08-09
00857136004057Surefire Guiding CatheterSGC-5065-Cobra12016-09-08
00857136004064Surefire Guiding CatheterSGC-5065-Sim12016-09-08
00857136004071Surefire Guiding CatheterSGC-5065-Axis2016-09-08
00857136004149Surefire Flexion Guiding CatheterSSG-5080-Axis2017-02-07
00857136004156Surefire Flexion Guiding CatheterSSG-5080-Sim12017-02-07
00857136004316TriNav XP Infusion SystemXPS-25130-352025-09-29
00857136004323TriNav XP Infusion SystemXPS-25150-352025-09-29
00857136004279TriNav FLX Infusion SystemFLX-21120-352025-04-15
00857136004286TriNav FLX Infusion SystemFLX-21150-352025-04-15
00857136004224TriNav LV Infusion SystemTVM-25120-502023-12-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810050863629Patient Loading Utility System (PLUS)LIFEPORT, LLCFOX2026-09-22
00628678604124Micro Base ProTechnimount Medicale IncFOX2026-09-21
00628678604131PS5000 Clamp Block FQTechnimount Medicale IncFOX2026-09-21
00628678604148Bracket Pro Serie® 350 – MDTechnimount Medicale IncFOX2026-09-21
00628678604155Bracket Pro Serie® 360 - FQTechnimount Medicale IncFOX2026-09-21
00628678604162Bracket Pro Serie® 71Technimount Medicale IncFOX2026-09-21
00628678604179O2 Mount PS5000Technimount Medicale IncFOX2026-09-21
00628678604186Bracket Pro Serie® 26 – FQTechnimount Medicale IncFOX2026-09-21
00628678604193CARDIATEK®Technimount Medicale IncFOX2026-09-21
00810050863612Patient Loading Utility System (PLUS)LIFEPORT, LLCFOX2026-09-21
00628678604087ContinuuMed™ RIVTechnimount Medicale IncFOX2026-09-18
00628678604094ContinuuMed™ PVTTechnimount Medicale IncFOX2026-09-18
00628678604100Standard Surface BaseTechnimount Medicale IncFOX2026-09-18
00628678604117Universal BaseTechnimount Medicale IncFOX2026-09-18
00810050863544Arch InstallationLIFEPORT, LLCFOX2026-08-25
00810050863551IV PoleLIFEPORT, LLCFOX2026-08-25
00810050863568Arch InstallationLIFEPORT, LLCFOX2026-08-25
00810050863575Arch AssemblyLIFEPORT, LLCFOX2026-08-25
00810050863506Medical CabinetLIFEPORT, LLCFOX2026-08-03
00841027105695Pedigo Products, Inc.PEDIGO PRODUCTS, INC.FOX2026-06-26
00810050863483AeroSled Transport Deck (TD)LIFEPORT, LLCFOX2026-06-08
00840117346307Vital Signs Stand, Compatible with item 10843Dynarex CorporationFOX2026-06-08
00761887005471PryorPRYOR PRODUCTSFOX2026-05-31
04061162002116CIM med GmbHCIM med GmbHFOX2026-05-31
04061162051893CIM med GmbHCIM med GmbHFOX2026-05-31
00885403530145TRUCLIPBecton, Dickinson And CompanyFOX2026-05-30
00840432200056Verathon®Verathon Medical (Canada) ULCFOX2026-05-28
00761887005426PryorPRYOR PRODUCTSFOX2026-05-21
00810050863445Patient Loading Utility System (PLUS)LIFEPORT, LLCFOX2026-05-15
00810050863452Patient Loading Utility System (PLUS)LIFEPORT, LLCFOX2026-05-15