DEVICE: ERBE (04050147012981)

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Device Record History
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Device Identifier (DI) Information
ERBE
20325-301
In Commercial Distribution
20325-301
Erbe Elektromedizin GmbH
04050147012981
GS1

1
316116623 *Terms of Use
Hybrid Tubing/Cap Set for Olympus® Scopes
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Device Characteristics
Labeling does not contain MRI Safety Information
No
No
No
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?
60738 Endoscopic insufflation tubing set, single-use
A collection of flexible tubing intended to channel medical gas [e.g., carbon dioxide (CO2), medical air] from its source into a body cavity for insufflation during endoscopy (e.g., gastrointestinal endoscopy, laparoscopy, arthroscopy). It includes synthetic polymer tubing and associated connectors; it may in addition be intended for endoscopic lens drying, and may include additional tubing for delivery of a sterile irrigation solution for endoscopic irrigation. This is a single-use device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
FEQ PUMP, AIR, NON-MANUAL, FOR ENDOSCOPE
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
K103696 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 dry
Special Storage Condition, Specify: Keep away from heat and direct sunlight
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Clinically Relevant Size

[?]
Size Type Text
Length: 3.500 Meter
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Device Record Status
859bada2-aa95-47c8-a8f4-3e90c57ba351
June 10, 2022
6
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
04050147013551 7 04050147012981 In Commercial Distribution Level: 1
04050147013568 5 04050147013551 In Commercial Distribution Level: 2
04050147022003 10 04050147012981 In Commercial Distribution Level: 1
04050147022010 3 04050147022003 In Commercial Distribution Level: 2
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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

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