Identity
- Trade Name
- Resp-O2 Oxygen CO2 Pressure Line Filters FDA UDI
- Generic Name
- Capnography sampling adaptor FDA UDI
- Model / Reference
- 33087 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840117316171 FDA UDI
- 510(k) Number
- K143150 FDA UDI
- FDA Product Code
- CCK FDA UDI
- GMDN Term
- Capnography sampling adaptor FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.1400 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Capnography sampling adaptor
Resp-O2 Oxygen CO2 Pressure Line Filters by Dynarex Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Capnography sampling adaptor.
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Cleared under the same submission
K143150 also covers:
- Resp-O2 EtCO2 Nasal Sampling Cannula — Dynarex Corp.
- Resp-O2 EtCO2 Nasal Sampling Cannula — Dynarex Corp.
- Resp-O2 EtCO2 Nasal Sampling Cannula — Dynarex Corp.
- Resp-O2 EtCO2 Nasal Sampling Cannula — Dynarex Corp.
- Resp-O2 EtCO2 Nasal Sampling Cannula — Dynarex Corp.
- Resp-O2 EtCO2 Nasal Sampling Cannula — Dynarex Corp.
- Resp-O2 EtCO2 Nasal Sampling Cannula — Dynarex Corp.
- Resp-O2 EtCO2 Nasal Sampling Cannula — Dynarex Corp.
- Resp-O2 EtCO2 Nasal Sampling Cannula — Dynarex Corp.
- Resp-O2 EtCO2 Nasal Sampling Cannula — Dynarex Corp.
- Resp-O2 EtCO2 Nasal Sampling Cannula — Dynarex Corp.
- Resp-O2 EtCO2 Nasal Sampling Cannula — Dynarex Corp.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Dynarex Corp.
Sources (1)
- FDA UDI f1341844-8fa4-4e3d-b003-a0e03a607438 33 fields · synced May 29, 2026