DEVICE: Pulmoguard (B279F0412050)
Device Identifier (DI) Information
Pulmoguard
II, Kushion Klip, Flotube
Not in Commercial Distribution
F0412-050
S D I DIAGNOSTICS INC
II, Kushion Klip, Flotube
Not in Commercial Distribution
F0412-050
S D I DIAGNOSTICS INC
Bacterial Filter
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
No | |
No | |
Yes | |
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? |
---|---|---|---|---|
60506 | Pulmonary function testing kit |
A collection of non-sterile devices intended to be used in conjunction with pulmonary function analysis equipment to perform a pulmonary function test. It may include a breathing mouthpiece, filter (intended to reduce contamination of parent device), and a nose clip. This is a single-use device.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
CAH | Filter, Bacterial, Breathing-Circuit |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K934509 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
192109ba-ac5b-4594-8b82-fdcfdbacc4b1
March 27, 2019
4
September 14, 2016
March 27, 2019
4
September 14, 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 |
---|---|---|---|---|---|
B279F0412200 | 50 | B279F0412050 | 2019-03-26 | Not in Commercial Distribution | case |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
B279F04120501
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined