FDA.reportPublic FDA data

Helium Supply Line (3 m), bar

Primary DI
00859019006059
Brand
Helium Supply Line (3 m), bar
Company
GALIL MEDICAL INC.
Model
FPRCH6105
Catalog number
FPRCH6105
Device description
Cryoablation System Accessory
Published
2016-08-15
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GEHUnit, Cryosurgical, Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEHUnit, Cryosurgical, AccessoriesGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K113860000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K113860000VISUAL-ICE CRYOABLATION SYSTEMGalil Medical, Inc.2012-03-12GEH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00859019006059PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00859019006059008590190060598590190060590859019006059

GMDN Terms#

Term, Definition table
TermDefinition
General cryosurgical system, cryogen gas, electronicAn assembly of mains electricity (AC-powered) devices designed to apply cold from a gaseous or liquid refrigerant (cryogen) [e.g., liquid nitrogen (LN2), nitrous oxide (N2O), carbon dioxide (CO2)] to a target tissue for its destruction and removal. The system typically includes an electronic control unit with LCD display to control the flow of cryogen from an attached cylinder, and sometimes to monitor skin temperature; and cryogen-cooled probes to apply the cold to tissues upon contact. It is used across clinical specialties (e.g., general surgery, dermatology, oral surgery, gynaecology, urology, ENT, proctology, oncology) to remove malignant or abnormal benign tissues.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length3Meter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in Visual-ICE Cryoablation System Storage Compartment

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
651-287-5000galil.cst@btgplc.com

Regulatory Flags#

DUNS number
809529469
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290104831171HEATfx 2.1 20cm NeedleFPRPR5101-02FPRPR5101-022020-10-30
07290104831188HEATfx 2.1 15cm NeedleFPRPR5102-02FPRPR5102-022020-10-30
00859019006936HEATfx Microwave Ablation SystemFPRCH9000-02FPRCH9000-022020-09-24
00859019006394HEATfx Microwave Ablation SystemFPRCH9000FPRCH90002020-08-14
07290104831140HEATfx 2.1 20cm NeedleFPRPR5101FPRPR51012020-08-14
07290104831157HEATfx 2.1 15cm NeedleFPRPR5102FPRPR51022020-08-14
00859019006318Visual-ICE MRI Cryoablation ConsoleFPRCH7000FPRCH70002018-03-07
00859019006325Visual-ICE MRI Junction Box AssemblyFPRCH7050 FPRCH7050 2018-03-07
00859019006332Visual-ICE MRI Mobile Connection PanelFPRCH7100FPRCH71002018-03-07
00867379000006Visual-ICE® Cryoablation SystemFPRCH6000FPRCH60002017-02-15
00859019006004EZ CONNECT2™ Dual Cylinder Adapter, psiFPRCH4000FPRCH40002016-08-15
00859019006011EZ CONNECT2™ Dual Cylinder Adapter, bar FPRCH4001FPRCH40012016-08-15
00859019006028Argon Supply Line (8 m), bar FPRCH6100FPRCH61002016-08-15
00859019006035Helium Supply Line (8 m), bar FPRCH6101FPRCH61012016-08-15
00859019006042Argon Supply Line (3 m), bar FPRCH6103FPRCH61032016-08-15
00859019006066Argon Supply Line (8 m), psi FPRCH6106FPRCH61062016-08-15
00859019006073Helium Supply Line (8 m), psi FPRCH6107FPRCH61072016-08-15
00859019006233Gas Supply Line (8 m) FPRCH6108FPRCH61082016-08-15
00859019006240Gas Supply Line (3 m) FPRCH6109FPRCH61092016-08-15
00859019006257Argon Auxiliary Line (3 m) FPRCH6115FPRCH61152016-08-15

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Primary DI, Brand, Company table
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30840143912164AtriCure® cryoICE® BOXATRICURE, INC.GEH2026-05-27
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