Duns Number:022721133
Device Description: SPIROMETER KITDISPOSABLE (single patient use)
Catalog Number
6500
Brand Name
n/a
Version/Model Number
6500
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
-
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
K863656,K863656,K863656
Product Code
BZG
Product Code Name
SPIROMETER, DIAGNOSTIC
Public Device Record Key
19e1b4b4-a371-4f11-a0ae-fc56701b3435
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
November 30, 2016
Package DI Number
20607411007594
Quantity per Package
50
Contains DI Package
10607411007597
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 865 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1134 |