DEVICE: NA (04055207014387)
Device Identifier (DI) Information
NA
8214074
Not in Commercial Distribution
8214.074
Richard Wolf GmbH
8214074
Not in Commercial Distribution
8214.074
Richard Wolf GmbH
BRONCHOSCOPE-TUBE ID 7.5MM model Hemer, OD 8.5mm, TL 400mm, with proximal illumination and sampling channel, without distal viewing window, graduated, reusable
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
No | |
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? |
---|---|---|---|---|
41126 | Bronchoscopy tube |
A hollow cylinder composed of plastic, rubber, or other material that is inserted orally into the trachea to maintain airway patency and/or to deliver anaesthetic inhalation agents or other medical gases, and secure ventilation during diagnostic or therapeutic bronchoscopy using a flexible bronchoscope. It has a cuff at the distal end, similar to that of a cuffed endotracheal (ET) tube and may be packaged with a connector that attaches to a breathing circuit. It has a large enough bore to accommodate a flexible bronchoscope; this can enhance the safety of the procedure. This is a single-use device.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
KTI | Bronchoscope accessory |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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Lumen/Inner Diameter: 7.5 Millimeter |
Device Record Status
6e48cbad-8aa4-4ee8-8601-6278660a62b6
August 19, 2022
4
September 23, 2016
August 19, 2022
4
September 23, 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 |
---|---|---|---|---|---|
No Package DIs found |
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
[?]
+497043350
info@richard-wolf.com
info@richard-wolf.com