Phenom™ Catheter FG11170-1015-2R

GUDID 00814584021401

Phenom™ 17 Catheter

CATHERA, INC.

Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use
Primary Device ID00814584021401
NIH Device Record Key6d590bb4-a8ec-4335-8eb5-f22ef6853acb
Commercial Distribution StatusIn Commercial Distribution
Brand NamePhenom™ Catheter
Version Model NumberFG11170-1015-2RV01
Catalog NumberFG11170-1015-2R
Company DUNS080116681
Company NameCATHERA, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1-949-837-3700
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Phone+1-949-837-3700
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Phone+1-949-837-3700
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Phone+1-949-837-3700
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Phone+1-949-837-3700
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Phone+1-949-837-3700
Emailcerreport@covidien.com
Phone+1-949-837-3700
Emailcerreport@covidien.com
Phone+1-949-837-3700
Emailcerreport@covidien.com
Phone+1-949-837-3700
Emailcerreport@covidien.com
Phone+1-949-837-3700
Emailcerreport@covidien.com
Phone+1-949-837-3700
Emailcerreport@covidien.com
Phone+1-949-837-3700
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Phone+1-949-837-3700
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Phone+1-949-837-3700
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Phone+1-949-837-3700
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Phone+1-949-837-3700
Emailcerreport@covidien.com
Phone+1-949-837-3700
Emailcerreport@covidien.com
Phone+1-949-837-3700
Emailcerreport@covidien.com
Phone+1-949-837-3700
Emailcerreport@covidien.com
Phone+1-949-837-3700
Emailcerreport@covidien.com
Phone+1-949-837-3700
Emailcerreport@covidien.com
Phone+1-949-837-3700
Emailcerreport@covidien.com
Phone+1-949-837-3700
Emailcerreport@covidien.com
Phone+1-949-837-3700
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Phone+1-949-837-3700
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Device Dimensions

Length170 Centimeter
Length170 Centimeter
Length170 Centimeter
Length170 Centimeter
Lumen/Inner Diameter0.017 Inch
Length170 Centimeter
Lumen/Inner Diameter0.017 Inch
Length170 Centimeter
Lumen/Inner Diameter0.017 Inch
Length170 Centimeter
Lumen/Inner Diameter0.017 Inch
Length170 Centimeter
Lumen/Inner Diameter0.017 Inch
Length170 Centimeter
Lumen/Inner Diameter0.017 Inch
Length170 Centimeter
Lumen/Inner Diameter0.017 Inch
Length170 Centimeter
Lumen/Inner Diameter0.017 Inch
Length170 Centimeter
Lumen/Inner Diameter0.017 Inch
Length170 Centimeter
Lumen/Inner Diameter0.017 Inch
Length170 Centimeter
Lumen/Inner Diameter0.017 Inch
Length170 Centimeter
Lumen/Inner Diameter0.017 Inch
Length170 Centimeter
Lumen/Inner Diameter0.017 Inch
Length170 Centimeter
Lumen/Inner Diameter0.017 Inch
Length170 Centimeter
Lumen/Inner Diameter0.017 Inch
Length170 Centimeter
Lumen/Inner Diameter0.017 Inch
Length170 Centimeter
Lumen/Inner Diameter0.017 Inch
Length170 Centimeter
Lumen/Inner Diameter0.017 Inch
Length170 Centimeter
Lumen/Inner Diameter0.017 Inch
Length170 Centimeter
Lumen/Inner Diameter0.017 Inch
Length170 Centimeter
Lumen/Inner Diameter0.017 Inch
Length170 Centimeter
Lumen/Inner Diameter0.017 Inch
Length170 Centimeter
Lumen/Inner Diameter0.017 Inch
Length170 Centimeter
Lumen/Inner Diameter0.017 Inch
Length170 Centimeter
Lumen/Inner Diameter0.017 Inch
Length170 Centimeter
Lumen/Inner Diameter0.017 Inch
Length170 Centimeter
Lumen/Inner Diameter0.017 Inch
Length170 Centimeter
Lumen/Inner Diameter0.017 Inch
Length170 Centimeter
Lumen/Inner Diameter0.017 Inch
Length170 Centimeter
Lumen/Inner Diameter0.017 Inch
Length170 Centimeter
Lumen/Inner Diameter0.017 Inch
Length170 Centimeter
Lumen/Inner Diameter0.017 Inch
Length170 Centimeter
Lumen/Inner Diameter0.017 Inch
Length170 Centimeter
Lumen/Inner Diameter0.017 Inch
Length170 Centimeter
Lumen/Inner Diameter0.017 Inch
Length170 Centimeter
Lumen/Inner Diameter0.017 Inch
Length170 Centimeter
Lumen/Inner Diameter0.017 Inch
Length170 Centimeter
Lumen/Inner Diameter0.017 Inch
Length170 Centimeter
Lumen/Inner Diameter0.017 Inch
Length170 Centimeter
Lumen/Inner Diameter0.017 Inch
Length170 Centimeter
Lumen/Inner Diameter0.017 Inch
Length170 Centimeter
Lumen/Inner Diameter0.017 Inch
Length170 Centimeter
Lumen/Inner Diameter0.017 Inch
Length170 Centimeter
Lumen/Inner Diameter0.017 Inch
Length170 Centimeter
Lumen/Inner Diameter0.017 Inch
Length170 Centimeter
Lumen/Inner Diameter0.017 Inch
Length170 Centimeter
Lumen/Inner Diameter0.017 Inch
Length170 Centimeter
Lumen/Inner Diameter0.017 Inch
Length170 Centimeter
Lumen/Inner Diameter0.017 Inch
Length170 Centimeter
Lumen/Inner Diameter0.017 Inch
Length170 Centimeter
Lumen/Inner Diameter0.017 Inch
Length170 Centimeter
Lumen/Inner Diameter0.017 Inch
Length170 Centimeter
Lumen/Inner Diameter0.017 Inch
Length170 Centimeter
Lumen/Inner Diameter0.017 Inch
Length170 Centimeter
Lumen/Inner Diameter0.017 Inch
Length170 Centimeter
Lumen/Inner Diameter0.017 Inch
Length170 Centimeter
Lumen/Inner Diameter0.017 Inch
Length170 Centimeter
Lumen/Inner Diameter0.017 Inch
Length170 Centimeter
Lumen/Inner Diameter0.017 Inch
Length170 Centimeter
Lumen/Inner Diameter0.017 Inch
Length170 Centimeter
Lumen/Inner Diameter0.017 Inch
Length170 Centimeter
Lumen/Inner Diameter0.017 Inch
Length170 Centimeter
Lumen/Inner Diameter0.017 Inch
Length170 Centimeter
Lumen/Inner Diameter0.017 Inch
Length170 Centimeter
Lumen/Inner Diameter0.017 Inch
Length170 Centimeter
Lumen/Inner Diameter0.017 Inch
Length170 Centimeter
Lumen/Inner Diameter0.017 Inch
Length170 Centimeter
Lumen/Inner Diameter0.017 Inch
Length170 Centimeter
Lumen/Inner Diameter0.017 Inch
Length170 Centimeter
Lumen/Inner Diameter0.017 Inch
Length170 Centimeter
Lumen/Inner Diameter0.017 Inch
Length170 Centimeter
Lumen/Inner Diameter0.017 Inch
Length170 Centimeter

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dark, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dark, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dark, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dark, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dark, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dark, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dark, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dark, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dark, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dark, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dark, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dark, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dark, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dark, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dark, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dark, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dark, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dark, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dark, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dark, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dark, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dark, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dark, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dark, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dark, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dark, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dark, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dark, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dark, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dark, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dark, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dark, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dark, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dark, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dark, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dark, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dark, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dark, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dark, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dark, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dark, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dark, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dark, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dark, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dark, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dark, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dark, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dark, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dark, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dark, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dark, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dark, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dark, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dark, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dark, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dark, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dark, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dark, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dark, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dark, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dark, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dark, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dark, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dark, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dark, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dark, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dark, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dark, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dark, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dark, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dark, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dark, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dark, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dark, dry place

Device Identifiers

Device Issuing AgencyDevice ID
GS100814584021401 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KRACatheter, Continuous Flush

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-01-23
Device Publish Date2016-10-20

On-Brand Devices [Phenom™ Catheter]

00814584029247Phenom™ Plus Catheter
00814584029230Phenom™ Plus Catheter
00814584029223Phenom™ Plus Catheter
00814584029216Phenom™ Plus Catheter
00814584029209Phenom™ Plus Catheter
00814584029193Phenom™ Plus Catheter
00814584029186Phenom™ Plus Catheter
00814584029179Phenom™ Plus Catheter
00814584029162Phenom™ Plus Catheter
00814584029155Phenom™ Plus Catheter
00814584029148Phenom™ Plus Catheter
00814584029131Phenom™ Plus Catheter
00814584029117Phenom™ Plus Catheter
00814584029100Phenom™ Plus Catheter
00814584029094Phenom™ Plus Catheter
00814584029025Phenom™ 27 Catheter
00814584029018Phenom™ 27 Catheter
00814584029001Phenom™ 27 Catheter
00814584028998Phenom™ 27 Catheter
00814584028981Phenom™ 27 Catheter
00814584028974Phenom™ 27 Catheter
00814584028967Phenom™ 27 Catheter
00814584028950Phenom™ 27 Catheter
00814584028943Phenom™ 27 Catheter
00814584028806Phenom™ 21 Catheter
00814584028790Phenom™ 21 Catheter
00814584028752Phenom™ 21 Catheter
00814584028745Phenom™ 21 Catheter
00814584028325Phenom™ 21 Catheter
00814584028318Phenom™ 21 Catheter
00814584028271Phenom™ 21 Catheter
00814584028264Phenom™ 21 Catheter
00814584027847Phenom™ 21 Catheter
00814584027830Phenom™ 21 Catheter
00814584027793Phenom™ 21 Catheter
00814584027786Phenom™ 21 Catheter
00814584027380Phenom™ 21 Catheter
00814584027373Phenom™ 21 Catheter
00814584027366Phenom™ 21 Catheter
00814584027359Phenom™ 21 Catheter
00814584027335Phenom™ 21 Catheter
00814584027328Phenom™ 21 Catheter
00814584027311Phenom™ 21 Catheter
00814584027304Phenom™ 21 Catheter
00814584026888Phenom™ 17 Catheter
00814584026871Phenom™ 17 Catheter
00814584026833Phenom™ 17 Catheter
00814584026826Phenom™ 17 Catheter
00814584026406Phenom™ 17 Catheter
00814584026390Phenom™ 17 Catheter

Trademark Results [Phenom]

Mark Image

Registration | Serial
Company
Trademark
Application Date
PHENOM
PHENOM
98488792 not registered Live/Pending
Andis Company
2024-04-08
PHENOM
PHENOM
98387244 not registered Live/Pending
VAP DIST LLC
2024-02-01
PHENOM
PHENOM
98168599 not registered Live/Pending
Agnetix, Inc.
2023-09-07
PHENOM
PHENOM
97878492 not registered Live/Pending
Phenom LLC
2023-04-07
PHENOM
PHENOM
97723612 not registered Live/Pending
VAP DIST LLC
2022-12-19
PHENOM
PHENOM
97632582 not registered Live/Pending
PHENOM ELITE LLC
2022-10-14
PHENOM
PHENOM
97266104 not registered Live/Pending
Agnetix, Inc.
2022-02-14
PHENOM
PHENOM
97265960 not registered Live/Pending
OM1, Inc.
2022-02-14
PHENOM
PHENOM
97065626 not registered Live/Pending
Skayl, LLC
2021-10-08
PHENOM
PHENOM
90566306 not registered Live/Pending
Edge-Works Manufacturing Company
2021-03-08
PHENOM
PHENOM
90398179 not registered Live/Pending
Phenom People, Inc.
2020-12-21
PHENOM
PHENOM
90383123 not registered Live/Pending
From the Soil LLC
2020-12-15
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