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Resp-O2 Oxygen CO2 Elongated Pediatric Mask CO2 Sampling Line with Filter
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- Resp-O2 Oxygen CO2 Elongated Pediatric Mask CO2 Sampling Line with Filter FDA UDI
- Generic Name
- Capnography sampling adaptor FDA UDI
- Device Name
- 7' (2.1m) Oxygen Tube; Male/Male connector FDA UDI
- Model / Reference
- 33081 FDA UDI
- Description
- 7' (2.1m) Oxygen Tube; Male/Male connector FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840117316119 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
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Capnography sampling adaptor
Resp-O2 Oxygen CO2 Elongated Pediatric Mask CO2 Sampling Line with Filter by Dynarex Corp. — Class II — FDA UDI — listed in FDA GUDID
Similar devices
Also classified as Capnography sampling adaptor.
- BCI — ICU MEDICAL, INC. · Class II
- CarboTrack — JADA Medical LLC · Class I
- BCI — ICU MEDICAL, INC. · Class II
- BCI — ICU MEDICAL, INC. · Class II
- Resp-O2 Oxygen CO2, 7'(2.1m) Sampling Line, Male / Male Connector — Dynarex Corp. · Class II
- Resp-O2 Oxygen CO2, 7'(2.1m) Sampling Line with Filter, Male/Female Connector — Dynarex Corp. · Class II
- Resp-O2 Oxygen CO2 7'(21.m) Sampling Line, Male/Female Connector — Dynarex Corp. · Class II
- Resp-O2 Oxygen CO2 Pressure Line Filters — Dynarex Corp. · Class II
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 bee1af48-c209-4a6d-8c2e-0231b7fe6284 34 fields · synced May 30, 2026