Duns Number:022721133
Device Description: Pocket Peak - standard range. 1230-0 part number taken out of commercial distributionCor
Catalog Number
1230-0
Brand Name
N/A
Version/Model Number
1230-0
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
October 01, 2018
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
K952713
Product Code
BZH
Product Code Name
METER, PEAK FLOW, SPIROMETRY
Public Device Record Key
97de736e-d0a5-4385-899f-e1f19183d227
Public Version Date
May 11, 2020
Public Version Number
5
DI Record Publish Date
September 24, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
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 |