Duns Number:008124539
Device Description: Resp-O2 Volumetric Incentive Spirometer 5000mL
Catalog Number
-
Brand Name
Resp-O2 Volumetric Incentive Spirometer
Version/Model Number
36101
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Safe
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
K141355,K141355
Product Code
BWF
Product Code Name
Spirometer, Therapeutic (Incentive)
Public Device Record Key
1a0f8b1b-2163-4f54-8c2e-38a050eee1de
Public Version Date
April 30, 2021
Public Version Number
1
DI Record Publish Date
April 22, 2021
Package DI Number
00840117318182
Quantity per Package
12
Contains DI Package
00840117320918
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 | 694 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 226 |
| 3 | A medical device with high risk that requires premarket approval | 2 |