DEVICE: DISPIRO (H6719502450)
Device Identifier (DI) Information
DISPIRO
Custom
In Commercial Distribution
950-245
UTAH MEDICAL PRODUCTS, INC.
Custom
In Commercial Distribution
950-245
UTAH MEDICAL PRODUCTS, INC.
Disposable Spirometer System Kit with 02401, 02020, 02013
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
Yes | |
Yes | |
Yes | |
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? |
---|---|---|---|---|
11850 | Gasometer |
A calibrated container that is usually balanced over water and intended to measure lung gas volumes. Also known as a wet spirometer. This GMDN code reflects old technology.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
BZG | Spirometer, Diagnostic |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K791177 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
70f2292d-ae16-40ac-9858-069bbea3c2c4
December 18, 2019
4
September 23, 2016
December 18, 2019
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 |
---|---|---|---|---|---|
H6719502452 | 4 | H6719502451 | In Commercial Distribution | Overpack | |
H6719502451 | 25 | H6719502450 | In Commercial Distribution | Box |
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
[?]
800-533-4984
customer@utahmed.com
customer@utahmed.com