DEVICE: NA (04055207033715)
Device Identifier (DI) Information
NA
825145030
In Commercial Distribution
82514.5030
Richard Wolf GmbH
825145030
In Commercial Distribution
82514.5030
Richard Wolf GmbH
BRONCHOSCOPE-TUBE ID 5.2MM Munich model, OD 5.8mm, TL 300mm, with proximal light connection, without distal viewing window, reusable
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
No | |
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 |
---|---|
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. |
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
No
Yes
CLOSE
Yes
Sterilization Method [?] |
---|
Moist Heat or Steam Sterilization |
Ethylene Oxide |
Hydrogen Peroxide |
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
Lumen/Inner Diameter: 5.2 Millimeter |
Device Record Status
977d3311-4f94-4179-97bf-b9563c3392ec
March 29, 2018
2
September 26, 2016
March 29, 2018
2
September 26, 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