DEVICE: ERBE (04050147013025)

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Device Identifier (DI) Information

ERBE
20325-308
20325-308
Erbe Elektromedizin GmbH
04050147013025
GS1
1
Hybrid CO2 Tubing/Cap Set for Fujinon® Scopes
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
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
Endoscopic insufflation tubing set, single-use A collection of sterile flexible tubing intended to be used as a conduit to deliver a medical gas [e.g., carbon dioxide (CO2), medical air] from its source for insufflation during an endoscopic (including laparoscopic, arthroscopic) procedure. It includes synthetic polymer tubing and associated connectors; it may in addition be intended for endoscopic lens drying, and may include tubing for delivery of a sterile irrigation solution for endoscopic irrigation. This is a single-use device.
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FDA Product Code

[?]
Product Code Product Code Name
FEQ PUMP, AIR, NON-MANUAL, FOR ENDOSCOPE
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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 heat and direct sunlight
Special Storage Condition, Specify: Keep dry
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Clinically Relevant Size

[?]
Size Type Text
Length: 3.500 Meter
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Device Status

In Commercial Distribution
December 15, 2016

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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
04050147013636 7 04050147013025 2017-01-16 Not in Commercial Distribution Level: 1
04050147013643 5 04050147013636 2017-01-16 Not in Commercial Distribution Level: 2
04050147021143 10 04050147013025 In Commercial Distribution Level: 1
04050147021150 3 04050147021143 In Commercial Distribution Level: 2
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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

[?]
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

[?]
+4970717550
info@erbe-med.com
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