DEVICE: FemoStop™ (05414734050036)

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Device Identifier (DI) Information

FemoStop™
Gold
C11165
ST. JUDE MEDICAL, INC.
05414734050036
GS1
1
Femoral Compression System
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Device Characteristics

Labeling does not contain MRI Safety Information
No
Yes
Yes
Yes
No
No
No
No

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Femoral artery compression system, single-use An assembly of sterile devices intended to be used in conjunction with manual compression to facilitate haemostasis to the puncture site on a patient having undergone femoral artery catheterization. It typically consists of a dedicated catheter with an elastomeric membrane at the distal tip and a tensioner. The catheter is inserted through the previously placed catheter introducer sheath and, once positioned, the membrane is deployed in the inner lumen of the femoral artery. Tension is applied to keep the membrane against the arteriotomy while the natural mechanisms of haemostasis are enacted. Once haemostasis is achieved, this device is removed. This is a single-use device.
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FDA Product Code

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Product Code Product Code Name
DXC CLAMP, VASCULAR
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Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
Special Storage Condition, Specify: Keep dry. Do not use if package is damaged.
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Status

In Commercial Distribution
April 19, 2016

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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
15414734050033 10 05414734050036 In Commercial Distribution
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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Yes
No
Yes
Yes
No CLOSE

Customer Contact

[?]
+1(855)478-5833
customerservice@sjm.com
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