Home GUDID 00814584021340 Phenom™ Catheter
Primary DI 00814584021340
Brand Phenom™ Catheter
Company CATHERA, INC.
Model FG11150-0615-2RV01
Catalog number FG11150-0615-2R
Device description Phenom™ 17 Catheter
Published 2016-10-20
Public version status Update
Distribution status Not in Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile true
Single use true Product Codes# Code, Name table Code Name DQY Catheter, Percutaneous KRA Catheter, Continuous Flush
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class DQY Catheter, Percutaneous Cardiovascular 2 KRA Catheter, Continuous Flush Cardiovascular 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00814584021340 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00814584021340 00814584021340 814584021340 0814584021340
GMDN Terms# Term, Definition table Term Definition Vascular guide-catheter, single-use A flexible tube intended to be used for the percutaneous transluminal passage and placement of a diagnostic/interventional catheter, lead (e.g., pacing lead, balloon dilatation catheter), needle or guidewire through its lumen(s), within the vascular system. It may be rigid or flexible, non-steerable or steerable, single or multiple lumen(s), and the distal section can have a variety of preformed shapes. It is not intended solely for infusion nor to access superselective small vessels, and does not include a transseptal needle. A percutaneous introduction set, shaft visualization electrodes, or haemostatic valve may be supplied with the guide-catheter. This is a single-use device.
Device Sizes# Type, Value, Unit table Type Value Unit Length 0 Lumen/Inner Diameter 0
Storage And Handling# Type, Low, High table Type Low High Condition Special Storage Condition, Specify 0 0 Store in a cool, dark, dry place
Regulatory Flags# DUNS number 080116681 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label false Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00814584020381 Phenom™ Catheter FG11150-0615-2SV01 FG11150-0615-2S 2016-10-20 00814584020398 Phenom™ Catheter FG11150-1015-2SV01 FG11150-1015-2S 2016-10-20 00814584020435 Phenom™ Catheter FG11170-0615-2SV01 FG11170-0615-2S 2016-10-20 00814584020442 Phenom™ Catheter FG11170-1015-2SV01 FG11170-1015-2S 2016-10-20 00814584020862 Phenom™ Catheter FG11150-0615-2XV01 FG11150-0615-2X 2016-10-20 00814584020879 Phenom™ Catheter FG11150-1015-2XV01 FG11150-1015-2X 2016-10-20 00814584020916 Phenom™ Catheter FG11170-0615-2XV01 FG11170-0615-2X 2016-10-20 00814584020923 Phenom™ Catheter FG11170-1015-2XV01 FG11170-1015-2X 2016-10-20 00814584021357 Phenom™ Catheter FG11150-1015-2RV01 FG11150-1015-2R 2016-10-20 00814584021395 Phenom™ Catheter FG11170-0615-2RV01 FG11170-0615-2R 2016-10-20 00814584021401 Phenom™ Catheter FG11170-1015-2RV01 FG11170-1015-2R 2016-10-20 00814584021821 Phenom™ Catheter FG11150-0615-2JV01 FG11150-0615-2J 2016-10-20 00814584021838 Phenom™ Catheter FG11150-1015-2JV01 FG11150-1015-2J 2016-10-20 00814584021876 Phenom™ Catheter FG11170-0615-2JV01 FG11170-0615-2J 2016-10-20 00814584021883 Phenom™ Catheter FG11170-1015-2JV01 FG11170-1015-2J 2016-10-20 00814584022309 Phenom™ Catheter FG13150-0615-2SV01 FG13150-0615-2S 2016-10-20 00814584022316 Phenom™ Catheter FG13150-1015-2SV01 FG13150-1015-2S 2016-10-20 00814584022354 Phenom™ Catheter FG13170-0615-2SV01 FG13170-0615-2S 2016-10-20 00814584022781 Phenom™ Catheter FG13150-0615-2XV01 FG13150-0615-2X 2016-10-20 00814584022798 Phenom™ Catheter FG13150-1015-2XV01 FG13150-1015-2X 2016-10-20
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