Duns Number:329769991
Device Description: ACC NASAL PROBE SET, Consits of1 EA 36-NPROBE01 Extra Small Nasal Probes 1 EA ACC NASAL PROBE SET, Consits of1 EA 36-NPROBE01 Extra Small Nasal Probes 1 EA 36-NPROBE02 Small Nasal Probes 1 EA 36-NPROBE03 Medium Nasal Probes 1 EA 36-NPROBE04 Large Nasal Probes
Catalog Number
36-NPROBE00
Brand Name
Micro Medical
Version/Model Number
36-NPROBE00
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
May 27, 2019
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
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
BYP
Product Code Name
Mouthpiece, Breathing
Public Device Record Key
e67de3e4-a0c1-4bb5-8f51-c958f35e6ebe
Public Version Date
March 16, 2021
Public Version Number
8
DI Record Publish Date
March 31, 2018
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 | 76 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 416 |