DEVICE: BS IS-1 (04035479144791)

Device Identifier (DI) Information

BS IS-1
330834
In Commercial Distribution
330834
BIOTRONIK SE & Co. KG
04035479144791
GS1

1
315620229 *Terms of Use
No description.
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Device Characteristics

MR Conditional
No
No
Yes
Yes
No
No
No
No

GMDN

[?]

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

GMDN Preferred Term Name GMDN Definition
Cardiac pulse generator port plug A device used to seal the unused connector port of an implantable pacemaker or an implantable cardioverter-defibrillator (ICD), to provide electrical isolation and protect the parent device from the extremely hostile environment of the human body when implanted. It is typically made of high-grade stainless steel and silicone, and is inserted sterile into the vacant port (e.g., an IS-1 connection). This is a single-use device.
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FDA Product Code

[?]
Product Code Product Code Name
DXY implantable pacemaker Pulse-generator
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
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Sterilization

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

[?]
Storage and Handling
Storage Environment Temperature: between 41 and 131 Degrees Fahrenheit
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

dcd47251-910f-47bd-ac67-b3ae127268d6
March 29, 2018
2
August 04, 2014
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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
04035479038403 10 04035479144791 In Commercial Distribution case
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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(888)345-0374
jon.brumbaugh@biotronik.com
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