DEVICE: Epi-Max™ Epistaxis Catheter (EBES60402P0)

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Device Record History
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Device Identifier (DI) Information
Epi-Max™ Epistaxis Catheter
60-402P
In Commercial Distribution

Boston Medical Products, Inc.
EBES60402P0
HIBCC

1
131855157 *Terms of Use
Size: 97 mm Length; Type: Anterior/Posterior
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Device Characteristics
MR Safe
No
Yes
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
12699 Nasal haemostatic balloon
A device consisting of a hollow rubber or rubber-like structure, expandable with either liquid or air, intended to be used to control nose bleeding (epistaxis) of the anterior or posterior nasal cavity. It is applied during an ear/nose/throat (ENT) intervention and can also be used to treat glue ear in children, and/or to support the structure and patency of the nasal canal. This is a single-use device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
EMX Balloon, Epistaxis
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
K972076 000
No CLOSE

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

[?]
Storage and Handling
Special Storage Condition, Specify: Keep away from sunlight
Special Storage Condition, Specify: Keep dry
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Clinically Relevant Size

[?]
Size Type Text
Length: 97 Millimeter
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Device Record Status
2f45a322-3f06-401f-8217-b11c1e92be23
August 30, 2022
6
March 28, 2017
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
1-800-433-2674
info@bosmed.com
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