FDA.reportPublic FDA data

Phenom™ Catheter

Primary DI
00814584020442
Brand
Phenom™ Catheter
Company
CATHERA, INC.
Model
FG11170-1015-2SV01
Catalog number
FG11170-1015-2S
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
DQYCatheter, Percutaneous
KRACatheter, Continuous Flush

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQYCatheter, PercutaneousCardiovascular2
KRACatheter, Continuous FlushCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00814584020442PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00814584020442008145840204428145840204420814584020442

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length0
Lumen/Inner Diameter0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in a cool, dark, dry place

Contacts#

Phone, Email table
PhoneEmail
+1-949-837-3700cerreport@covidien.com

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 DIBrandModelCatalogPublished
00814584020381Phenom™ CatheterFG11150-0615-2SV01FG11150-0615-2S2016-10-20
00814584020398Phenom™ CatheterFG11150-1015-2SV01FG11150-1015-2S2016-10-20
00814584020435Phenom™ CatheterFG11170-0615-2SV01FG11170-0615-2S2016-10-20
00814584020862Phenom™ CatheterFG11150-0615-2XV01FG11150-0615-2X2016-10-20
00814584020879Phenom™ CatheterFG11150-1015-2XV01FG11150-1015-2X2016-10-20
00814584020916Phenom™ CatheterFG11170-0615-2XV01FG11170-0615-2X2016-10-20
00814584020923Phenom™ CatheterFG11170-1015-2XV01FG11170-1015-2X2016-10-20
00814584021340Phenom™ CatheterFG11150-0615-2RV01FG11150-0615-2R2016-10-20
00814584021357Phenom™ CatheterFG11150-1015-2RV01FG11150-1015-2R2016-10-20
00814584021395Phenom™ CatheterFG11170-0615-2RV01FG11170-0615-2R2016-10-20
00814584021401Phenom™ CatheterFG11170-1015-2RV01FG11170-1015-2R2016-10-20
00814584021821Phenom™ CatheterFG11150-0615-2JV01FG11150-0615-2J2016-10-20
00814584021838Phenom™ CatheterFG11150-1015-2JV01FG11150-1015-2J2016-10-20
00814584021876Phenom™ CatheterFG11170-0615-2JV01FG11170-0615-2J2016-10-20
00814584021883Phenom™ CatheterFG11170-1015-2JV01FG11170-1015-2J2016-10-20
00814584022309Phenom™ CatheterFG13150-0615-2SV01FG13150-0615-2S2016-10-20
00814584022316Phenom™ CatheterFG13150-1015-2SV01FG13150-1015-2S2016-10-20
00814584022354Phenom™ CatheterFG13170-0615-2SV01FG13170-0615-2S2016-10-20
00814584022781Phenom™ CatheterFG13150-0615-2XV01FG13150-0615-2X2016-10-20
00814584022798Phenom™ CatheterFG13150-1015-2XV01FG13150-1015-2X2016-10-20

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07613327682441Excelsior ReachStryker CorporationDQY2026-10-29
07613327682458Excelsior ReachStryker CorporationDQY2026-10-29
07613327682465Excelsior ReachStryker CorporationDQY2026-10-29
07613327682496Excelsior ReachStryker CorporationDQY2026-10-29
07613327682526Excelsior ReachStryker CorporationDQY2026-10-29
07613327682571Excelsior ReachStryker CorporationDQY2026-10-29
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00860014559273Powered Aventus Thrombectomy CatheterInquis Medical, Inc.KRA2026-10-19
00802526625008ACUITY™BOSTON SCIENTIFIC CORPORATIONDQY2026-10-15
05391547390019InVera Infusion DeviceINVERA MEDICAL LIMITEDKRA2026-10-09
0086001552773870 NeuGlide CatheterPIRAEUS MEDICAL INC.DQY2026-10-06
0086001552774570 NeuGlide CatheterPIRAEUS MEDICAL INC.DQY2026-10-06
00810068568998Next Generation 088 CatheterBALT USA LLCDQY2026-10-01
00840303713104Next Generation 088 CatheterBALT USA LLCDQY2026-10-01
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00857136004293TriNav Advance Infusion SystemSUREFIRE MEDICAL, INC.KRA2026-09-24
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00857136004415TriNav Advance Infusion SystemSUREFIRE MEDICAL, INC.KRA2026-09-24
00884450416723SureCrossMerit Medical Systems, Inc.DQY2026-09-22
00884450422755SureCrossMerit Medical Systems, Inc.DQY2026-09-22
00884450423110SureCrossMerit Medical Systems, Inc.DQY2026-09-22
00884450427170SureCrossMerit Medical Systems, Inc.DQY2026-09-22
10886704074892ENVOYCerenovus, Inc.DQY2026-09-19