FDA.reportPublic FDA data

CarboJet® CO2 Bone Lavage System

Primary DI
00818720011752
Brand
CarboJet® CO2 Bone Lavage System
Company
Kinamed, Inc.
Model
25-200-0150
Catalog number
25-200-0150
Device description
BOOM/HEADWALL SOURCE CO2 ADAPTOR - DISS
Published
2016-05-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
FQHLAVAGE, JET

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FQHLavage, JetGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00818720011752PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00818720011752008187200117528187200117520818720011752

GMDN Terms#

Term, Definition table
TermDefinition
Carbon dioxide 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 carbon dioxide (CO2) cylinder to lower high, variable gas pressure (e.g., 50 - 150 bar) to a lower, constant working pressure, typically 3 - 5 bar. 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 it may have associated devices, usually a manometer or manometers, to display the available gas reserve of a gas cylinder and the working pressure.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
184896645
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00818720011608SuperCable® Grip and Plate System35-860-206535-860-20652023-06-21
00818720011547SuperCable® Grip and Plate System35-860-102035-860-10202023-06-20
00818720011578SuperCable® Grip and Plate System35-860-202035-860-20202023-06-20
00818720011585SuperCable® Grip and Plate System35-860-203035-860-20302023-06-20
00898142001357SuperCable® Iso-Elastic™ Cerclage System35-100-101035-100-10102015-11-04
00898142001975SuperCable® Iso-Elastic™ Cerclage System37-100-101037-100-10102015-11-04
00818720012438CarboJet XF® Bone Preparation System27-100-114027-100-11402023-07-10
00818720010007SuperCable® Grip and Plate System35-200-101035-200-10102015-10-28
00818720010014SuperCable® Grip and Plate System35-200-102035-200-10202015-10-28
00818720010021SuperCable® Grip and Plate System35-200-103035-200-10302015-10-28
00818720010038SuperCable® Grip and Plate System35-200-104035-200-10402015-10-27
00818720010069SuperCable® Grip and Plate System35-220-101035-220-10102015-10-28
00818720010076SuperCable® Grip and Plate System35-220-201035-220-20102015-10-28
00818720010083SuperCable® Grip and Plate System35-220-201235-220-20122015-10-28
00818720010090SuperCable® Grip and Plate System35-220-301035-220-30102015-10-28
00818720010106SuperCable® Grip and Plate System35-220-301235-220-30122015-10-28
00818720010113SuperCable® Grip and Plate System35-230-451035-230-45102015-10-30
00818720010120SuperCable® Grip and Plate System35-230-451235-230-45122015-10-30
00818720010137SuperCable® Grip and Plate System35-230-451435-230-45142015-10-30
00818720010144SuperCable® Grip and Plate System35-230-451635-230-45162015-10-30

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