MAXIFLO™ W45T0407

GUDID 05037881009933

MAXIFLO ePTFE Vascular Prosthesis Short Taper with Wrap

VASCUTEK LTD

Synthetic vascular graft
Primary Device ID05037881009933
NIH Device Record Key9bbc6c4a-e9a6-44aa-b3c4-d6ea0480aaec
Commercial Distribution StatusIn Commercial Distribution
Brand NameMAXIFLO™
Version Model NumberW45T0407
Catalog NumberW45T0407
Company DUNS229053087
Company NameVASCUTEK LTD
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 Numbertrue
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)888-3786
Emailtmccustomer.admin@terumomedical.com
Phone+1(800)888-3786
Emailtmccustomer.admin@terumomedical.com
Phone+1(800)888-3786
Emailtmccustomer.admin@terumomedical.com
Phone+1(800)888-3786
Emailtmccustomer.admin@terumomedical.com
Phone+1(800)888-3786
Emailtmccustomer.admin@terumomedical.com
Phone+1(800)888-3786
Emailtmccustomer.admin@terumomedical.com
Phone+1(800)888-3786
Emailtmccustomer.admin@terumomedical.com
Phone+1(800)888-3786
Emailtmccustomer.admin@terumomedical.com
Phone+1(800)888-3786
Emailtmccustomer.admin@terumomedical.com
Phone+1(800)888-3786
Emailtmccustomer.admin@terumomedical.com
Phone+1(800)888-3786
Emailtmccustomer.admin@terumomedical.com
Phone+1(800)888-3786
Emailtmccustomer.admin@terumomedical.com
Phone+1(800)888-3786
Emailtmccustomer.admin@terumomedical.com
Phone+1(800)888-3786
Emailtmccustomer.admin@terumomedical.com
Phone+1(800)888-3786
Emailtmccustomer.admin@terumomedical.com
Phone+1(800)888-3786
Emailtmccustomer.admin@terumomedical.com
Phone+1(800)888-3786
Emailtmccustomer.admin@terumomedical.com
Phone+1(800)888-3786
Emailtmccustomer.admin@terumomedical.com
Phone+1(800)888-3786
Emailtmccustomer.admin@terumomedical.com
Phone+1(800)888-3786
Emailtmccustomer.admin@terumomedical.com
Phone+1(800)888-3786
Emailtmccustomer.admin@terumomedical.com
Phone+1(800)888-3786
Emailtmccustomer.admin@terumomedical.com
Phone+1(800)888-3786
Emailtmccustomer.admin@terumomedical.com
Phone+1(800)888-3786
Emailtmccustomer.admin@terumomedical.com
Phone+1(800)888-3786
Emailtmccustomer.admin@terumomedical.com

Device Dimensions

Device Size Text, specify0
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Length45 Centimeter
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Length45 Centimeter
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Length45 Centimeter
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Length45 Centimeter
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Length45 Centimeter
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Length45 Centimeter
Device Size Text, specify0
Length45 Centimeter
Device Size Text, specify0
Length45 Centimeter
Device Size Text, specify0
Length45 Centimeter
Device Size Text, specify0
Length45 Centimeter
Device Size Text, specify0
Length45 Centimeter
Device Size Text, specify0
Length45 Centimeter
Device Size Text, specify0
Length45 Centimeter
Device Size Text, specify0
Length45 Centimeter
Device Size Text, specify0
Length45 Centimeter
Device Size Text, specify0
Length45 Centimeter
Device Size Text, specify0
Length45 Centimeter
Device Size Text, specify0
Length45 Centimeter
Device Size Text, specify0
Length45 Centimeter
Device Size Text, specify0
Length45 Centimeter
Device Size Text, specify0
Length45 Centimeter
Device Size Text, specify0
Length45 Centimeter
Device Size Text, specify0
Length45 Centimeter
Device Size Text, specify0
Length45 Centimeter
Device Size Text, specify0

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, dry area at room temperature. Do not expose ePTFE products to temperature greater than 260°C (500°F).
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, dry area at room temperature. Do not expose ePTFE products to temperature greater than 260°C (500°F).
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, dry area at room temperature. Do not expose ePTFE products to temperature greater than 260°C (500°F).
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, dry area at room temperature. Do not expose ePTFE products to temperature greater than 260°C (500°F).
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, dry area at room temperature. Do not expose ePTFE products to temperature greater than 260°C (500°F).
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, dry area at room temperature. Do not expose ePTFE products to temperature greater than 260°C (500°F).
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, dry area at room temperature. Do not expose ePTFE products to temperature greater than 260°C (500°F).
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, dry area at room temperature. Do not expose ePTFE products to temperature greater than 260°C (500°F).
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, dry area at room temperature. Do not expose ePTFE products to temperature greater than 260°C (500°F).
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, dry area at room temperature. Do not expose ePTFE products to temperature greater than 260°C (500°F).
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, dry area at room temperature. Do not expose ePTFE products to temperature greater than 260°C (500°F).
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, dry area at room temperature. Do not expose ePTFE products to temperature greater than 260°C (500°F).
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, dry area at room temperature. Do not expose ePTFE products to temperature greater than 260°C (500°F).
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, dry area at room temperature. Do not expose ePTFE products to temperature greater than 260°C (500°F).
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, dry area at room temperature. Do not expose ePTFE products to temperature greater than 260°C (500°F).
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, dry area at room temperature. Do not expose ePTFE products to temperature greater than 260°C (500°F).
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, dry area at room temperature. Do not expose ePTFE products to temperature greater than 260°C (500°F).
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, dry area at room temperature. Do not expose ePTFE products to temperature greater than 260°C (500°F).
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, dry area at room temperature. Do not expose ePTFE products to temperature greater than 260°C (500°F).
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, dry area at room temperature. Do not expose ePTFE products to temperature greater than 260°C (500°F).
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, dry area at room temperature. Do not expose ePTFE products to temperature greater than 260°C (500°F).
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, dry area at room temperature. Do not expose ePTFE products to temperature greater than 260°C (500°F).
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, dry area at room temperature. Do not expose ePTFE products to temperature greater than 260°C (500°F).
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, dry area at room temperature. Do not expose ePTFE products to temperature greater than 260°C (500°F).
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, dry area at room temperature. Do not expose ePTFE products to temperature greater than 260°C (500°F).

Device Identifiers

Device Issuing AgencyDevice ID
GS105037881009933 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DSYPROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2020-03-24
Device Publish Date2015-09-23

On-Brand Devices [MAXIFLO™]

05037881152349MAXIFLO ePTFE Vascular Prosthesis ULTRATHIN WALL STRAIGHT WRAPPED, FULLY REINFORCED WITH A PTFE
05037881152332MAXIFLO ePTFE Vascular Prosthesis ULTRATHIN WALL STRAIGHT WRAPPED, FULLY REINFORCED WITH A PTFE
05037881152325MAXIFLO ePTFE Vascular Prosthesis ULTRATHIN WALL STRAIGHT WRAPPED, FULLY REINFORCED WITH A PTFE
05037881152318MAXIFLO ePTFE Vascular Prosthesis ULTRATHIN WALL STRAIGHT WRAPPED, FULLY REINFORCED WITH A PTFE
05037881152301MAXIFLO ePTFE Vascular Prosthesis ULTRATHIN WALL STRAIGHT WRAPPED, FULLY REINFORCED WITH A PTFE
05037881152295MAXIFLO ePTFE Vascular Prosthesis ULTRATHIN WALL STRAIGHT WRAPPED, FULLY REINFORCED WITH A PTFE
05037881152288MAXIFLO ePTFE Vascular Prosthesis ULTRATHIN WALL STRAIGHT WRAPPED, FULLY REINFORCED WITH A PTFE
05037881152271MAXIFLO ePTFE Vascular Prosthesis ULTRATHIN WALL STRAIGHT WRAPPED, FULLY REINFORCED WITH A PTFE
05037881152264MAXIFLO ePTFE Vascular Prosthesis ULTRATHIN WALL STRAIGHT WRAPPED, FULLY REINFORCED WITH A PTFE
05037881152257MAXIFLO ePTFE Vascular Prosthesis ULTRATHIN WALL STRAIGHT WRAPPED, FULLY REINFORCED WITH A PTFE
05037881152240MAXIFLO ePTFE Vascular Prosthesis ULTRATHIN WALL STRAIGHT WRAPPED, FULLY REINFORCED WITH A PTFE
05037881152233MAXIFLO ePTFE Vascular Prosthesis ULTRATHIN WALL STRAIGHT WRAPPED, FULLY REINFORCED WITH A PTFE
05037881152226MAXIFLO ePTFE Vascular Prosthesis ULTRATHIN WALL STRAIGHT WRAPPED, FULLY REINFORCED WITH A PTFE
05037881152219MAXIFLO ePTFE Vascular Prosthesis ULTRATHIN WALL STRAIGHT WRAPPED, FULLY REINFORCED WITH A PTFE
05037881152202MAXIFLO ePTFE Vascular Prosthesis ULTRATHIN WALL STRAIGHT WRAPPED, FULLY REINFORCED WITH A PTFE
05037881152196MAXIFLO ePTFE Vascular Prosthesis ULTRATHIN WALL STRAIGHT WRAPPED, FULLY REINFORCED WITH A PTFE
05037881152189MAXIFLO ePTFE Vascular Prosthesis ULTRATHIN WALL STRAIGHT WRAPPED, FULLY REINFORCED WITH A PTFE
05037881152172MAXIFLO ePTFE Vascular Prosthesis ULTRATHIN WALL STRAIGHT WRAPPED, FULLY REINFORCED WITH A PTFE
05037881152165MAXIFLO ePTFE Vascular Prosthesis ULTRATHIN WALL STRAIGHT WRAPPED, FULLY REINFORCED WITH A PTFE
05037881152158MAXIFLO ePTFE Vascular Prosthesis ULTRATHIN WALL STRAIGHT WRAPPED, FULLY REINFORCED WITH A PTFE
05037881152141MAXIFLO ePTFE Vascular Prosthesis ULTRATHIN WALL STRAIGHT WRAPPED, FULLY REINFORCED WITH A PTFE
05037881152134MAXIFLO ePTFE Vascular Prosthesis ULTRATHIN WALL STRAIGHT WRAPPED, FULLY REINFORCED WITH A PTFE
05037881152127MAXIFLO ePTFE Vascular Prosthesis ULTRATHIN WALL STRAIGHT WRAPPED, FULLY REINFORCED WITH A PTFE
05037881152110MAXIFLO ePTFE Vascular Prosthesis ULTRATHIN WALL STRAIGHT WRAPPED, FULLY REINFORCED WITH A PTFE
05037881152097MAXIFLO ePTFE Vascular Prosthesis ULTRATHIN WALL STRAIGHT WRAPPED, FULLY REINFORCED WITH A PTFE
05037881152080MAXIFLO ePTFE Vascular Prosthesis ULTRATHIN WALL STRAIGHT WRAPPED, FULLY REINFORCED WITH A PTFE
05037881152073MAXIFLO ePTFE Vascular Prosthesis ULTRATHIN WALL STRAIGHT WRAPPED, FULLY REINFORCED WITH A PTFE
05037881152066MAXIFLO ePTFE Vascular Prosthesis ULTRATHIN WALL STRAIGHT WRAPPED, FULLY REINFORCED WITH A PTFE
05037881152042MAXIFLO ePTFE Vascular Prosthesis ULTRATHIN WALL STRAIGHT WRAPPED, FULLY REINFORCED WITH A PTFE
05037881152035MAXIFLO ePTFE Vascular Prosthesis ULTRATHIN WALL STRAIGHT WRAPPED, FULLY REINFORCED WITH A PTFE
05037881152028MAXIFLO ePTFE Vascular Prosthesis ULTRATHIN WALL STRAIGHT WRAPPED, FULLY REINFORCED WITH A PTFE
05037881152011ePTFE ULTRATHIN WALL STRAIGHT WRAPPED, FULLY REINFORCED WITH A PTFE SUPPORT
05037881151991MAXIFLO ePTFE Vascular Prosthesis
05037881151984MAXIFLO ePTFE Vascular Prosthesis Wrap with Unity Construction ULTRATHIN WALL STRAIGHT WRAPPED,
05037881151977MAXIFLO ePTFE Vascular Prosthesis ULTRATHIN WALL STRAIGHT WRAPPED, FULLY REINFORCED WITH A PTFE
05037881151960MAXIFLO ePTFE Vascular Prosthesis ULTRATHIN WALL STRAIGHT WRAPPED, FULLY REINFORCED WITH A PTFE
05037881151946MAXIFLO ePTFE Vascular Prosthesis STANDARD WALL STRAIGHT WRAPPED, FULLY REINFORCED WITH A PTFE
05037881151939MAXIFLO ePTFE Vascular Prosthesis STANDARD WALL STRAIGHT WRAPPED, FULLY REINFORCED WITH A PTFE
05037881151922MAXIFLO ePTFE Vascular Prosthesis STANDARD WALL STRAIGHT WRAPPED, FULLY REINFORCED WITH A PTFE
05037881151915MAXIFLO ePTFE Vascular Prosthesis STANDARD WALL STRAIGHT WRAPPED, FULLY REINFORCED WITH A PTFE
05037881151892MAXIFLO ePTFE Vascular Prosthesis STANDARD WALL STRAIGHT WRAPPED, FULLY REINFORCED WITH A PTFE
05037881151885MAXIFLO ePTFE Vascular Prosthesis STANDARD WALL STRAIGHT WRAPPED, FULLY REINFORCED WITH A PTFE
05037881151878MAXIFLO ePTFE Vascular Prosthesis STANDARD WALL STRAIGHT WRAPPED, FULLY REINFORCED WITH A PTFE
05037881151861MAXIFLO ePTFE Vascular Prosthesis STANDARD WALL STRAIGHT WRAPPED, FULLY REINFORCED WITH A PTFE
05037881151847MAXIFLO ePTFE Vascular Prosthesis STANDARD WALL STRAIGHT WRAPPED, FULLY REINFORCED WITH A PTFE
05037881151830MAXIFLO ePTFE Vascular Prosthesis STANDARD WALL STRAIGHT WRAPPED, FULLY REINFORCED WITH A PTFE
05037881151823MAXIFLO ePTFE Vascular Prosthesis STANDARD WALL STRAIGHT WRAPPED, FULLY REINFORCED WITH A PTFE
05037881151816MAXIFLO ePTFE Vascular Prosthesis STANDARD WALL STRAIGHT WRAPPED, FULLY REINFORCED WITH A PTFE
05037881151809MAXIFLO ePTFE Vascular Prosthesis STANDARD WALL STRAIGHT WRAPPED, FULLY REINFORCED WITH A PTFE
05037881151793MAXIFLO ePTFE Vascular Prosthesis STANDARD WALL STRAIGHT WRAPPED, FULLY REINFORCED WITH A PTFE

Trademark Results [MAXIFLO]

Mark Image

Registration | Serial
Company
Trademark
Application Date
MAXIFLO
MAXIFLO
90009006 not registered Live/Pending
AIREAU QUALITÉ CONTRÔLE INC.
2020-06-18
MAXIFLO
MAXIFLO
78075914 not registered Dead/Abandoned
Maxiflo
2001-07-26
MAXIFLO
MAXIFLO
77377686 3578897 Dead/Cancelled
RBH/MILL & ELEVATOR SUPPLY, INC.
2008-01-22
MAXIFLO
MAXIFLO
74559161 1994003 Live/Registered
COVIDIEN LP
1994-08-10
MAXIFLO
MAXIFLO
73392789 not registered Dead/Abandoned
AQUALITY, INC.
1982-09-29
MAXIFLO
MAXIFLO
72018422 0645105 Dead/Expired
ENGINE LIFE PRODUCTS CORPORATION
1956-10-30

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