Angio-Seal™ 610131

GUDID 25415067002857

ST. JUDE MEDICAL CARDIOVASCULAR DIVISION

Femoral artery closure plug/patch, collagen
Primary Device ID25415067002857
NIH Device Record Keyf1e19321-14a9-4992-ab47-298f3abaa46d
Commercial Distribution Discontinuation2017-04-20
Commercial Distribution StatusNot in Commercial Distribution
Brand NameAngio-Seal™
Version Model NumberVIP
Catalog Number610131
Company DUNS040960379
Company NameST. JUDE MEDICAL CARDIOVASCULAR DIVISION
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Safe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
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(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com

Device Dimensions

Catheter Gauge8 French
Catheter Gauge8 French
Catheter Gauge8 French
Catheter Gauge8 French
Catheter Gauge8 French
Catheter Gauge8 French
Catheter Gauge8 French
Catheter Gauge8 French
Catheter Gauge8 French
Catheter Gauge8 French

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and Keep away from sunlight. Do not use if temperature indicator dot has changed from light gray to dark gray or black.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and Keep away from sunlight. Do not use if temperature indicator dot has changed from light gray to dark gray or black.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and Keep away from sunlight. Do not use if temperature indicator dot has changed from light gray to dark gray or black.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and Keep away from sunlight. Do not use if temperature indicator dot has changed from light gray to dark gray or black.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and Keep away from sunlight. Do not use if temperature indicator dot has changed from light gray to dark gray or black.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and Keep away from sunlight. Do not use if temperature indicator dot has changed from light gray to dark gray or black.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and Keep away from sunlight. Do not use if temperature indicator dot has changed from light gray to dark gray or black.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and Keep away from sunlight. Do not use if temperature indicator dot has changed from light gray to dark gray or black.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and Keep away from sunlight. Do not use if temperature indicator dot has changed from light gray to dark gray or black.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and Keep away from sunlight. Do not use if temperature indicator dot has changed from light gray to dark gray or black.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS105415067002853 [Primary]
GS115415067002850 [Package]
Package: [2 Units]
Discontinued: 2017-04-20
Not in Commercial Distribution
GS125415067002857 [Package]
Contains: 05415067002853
Package: [5 Units]
Discontinued: 2017-04-20
Not in Commercial Distribution

FDA Product Code

MGBDEVICE, HEMOSTASIS, VASCULAR

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-10-22
Device Publish Date2014-10-24

On-Brand Devices [Angio-Seal™]

05415067002877STS Plus
05415067002860STS Plus
25415067002857VIP
05415067002846Evolution™
05415067002839Evolution™
05414734054591VIP

Trademark Results [Angio-Seal]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ANGIO-SEAL
ANGIO-SEAL
88050352 5696539 Live/Registered
Terumo Puerto Rico, L.L.C.
2018-07-24
ANGIO-SEAL
ANGIO-SEAL
75005288 2118314 Dead/Cancelled
QUINTON INSTRUMENT COMPANY
1995-10-13
ANGIO-SEAL
ANGIO-SEAL
74666330 2154010 Live/Registered
TERUMO PUERTO RICO L.L.C.
1995-04-27
ANGIO-SEAL
ANGIO-SEAL
74344004 not registered Dead/Abandoned
QUINTON INSTRUMENT COMPANY
1992-12-23

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