DEVICE: ERBE (04050147013070)
Device Identifier (DI) Information
ERBE
20325-332
In Commercial Distribution
20325-332
Erbe Elektromedizin GmbH
20325-332
In Commercial Distribution
20325-332
Erbe Elektromedizin GmbH
Air and Water Tubing/Cap Set for Pentax® Scopes
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. The copyright and database rights in the original GMDN materials are owned by The GMDN Agency Ltd 2005-2023. 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 |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
FEQ | PUMP, AIR, NON-MANUAL, FOR ENDOSCOPE |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K132340 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Special Storage Condition, Specify: Keep away from heat and direct sunlight |
Special Storage Condition, Specify: Keep dry |
Clinically Relevant Size
[?]Size Type Text |
---|
Length: 0.400 Meter |
Device Record Status
db88a84f-28f8-42d2-b693-37abf1055510
June 10, 2022
5
December 15, 2016
June 10, 2022
5
December 15, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
04050147013742 | 5 | 04050147013735 | In Commercial Distribution | Level: 2 | |
04050147013735 | 10 | 04050147013070 | In Commercial Distribution | Level: 1 |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+4970717550
info@erbe-med.com
info@erbe-med.com