Duns Number:025460908
Device Description: FILTER,PULM,FUNCTION,ROUND,REG,BLUE
Catalog Number
DYNJ760B
Brand Name
Medline
Version/Model Number
DYNJ760B
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
Yes
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K042758,K042758
Product Code
BZG
Product Code Name
SPIROMETER, DIAGNOSTIC
Public Device Record Key
97f0d6f8-e943-4fb6-837b-3dced85e5476
Public Version Date
November 08, 2021
Public Version Number
1
DI Record Publish Date
October 29, 2021
Package DI Number
20888277652443
Quantity per Package
100
Contains DI Package
10888277652446
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CASE
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 38540 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 85094 |
| 3 | A medical device with high risk that requires premarket approval | 2 |
| U | Unclassified | 7 |