Duns Number:195929658
Device Description: Futuremed Spirometry filter with oval mouthpiece, for use with pulmonary function testing Futuremed Spirometry filter with oval mouthpiece, for use with pulmonary function testing equipment. 31mm OD.
Catalog Number
39NAE-XXX
Brand Name
FUTUREMED
Version/Model Number
39NA Oval PFT Filter
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"
-
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
K000654,K000654
Product Code
CAH
Product Code Name
Filter, Bacterial, Breathing-Circuit
Public Device Record Key
5b626861-2d06-4b6c-ac1a-a365af1ab7f8
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
October 24, 2017
Package DI Number
00853452007185
Quantity per Package
200
Contains DI Package
00853452007178
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box of 200
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 5 |