Analyzer, Nitrogen Dioxide, Exempt
PUG is the FDA product code for Analyzer, Nitrogen Dioxide, Exempt, a class II device type, regulated under 21 CFR 868.2385. FDA's definition for this code reads: "This product code is the class II exempt counterpart of MRQ, and was exempted, subject to the limitations of exemption, under the procedures established by the 21st Century Cures Act. This device type does not require premarket notification (510(k)) to market if it does not exceed the general limitations of exemption...". As of , FDA records hold no 510(k) clearances under this code and no recalls.
Classification record
- Product code
- PUG
- Device name
- Analyzer, Nitrogen Dioxide, Exempt
- FDA definition
- This product code is the class II exempt counterpart of MRQ, and was exempted, subject to the limitations of exemption, under the procedures established by the 21st Century Cures Act. This device type does not require premarket notification (510(k)) to market if it does not exceed the general limitations of exemption found in 21 CFR 868.9 and the specific limitations of exemption as stated in the “Physical State” field of this product code description.
- Regulation
- 21 CFR 868.2385
- Device class
- Class II
- Review panel
- Anesthesiology
- Submission type
- 510(k) exempt
- Implant
- No
- Life sustaining or supporting
- Yes
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 0
- Ingested recalls
- 0
Companies listing this code with FDA
Companies whose registered establishments list this codeNo registered establishment in MDM’s records lists product code PUG.
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