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Sentri Intersurgical Ecolite, Adult, Mask With Co2 Monitoring Line
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- SENTRI INTERSURGICAL ECOLITE, ADULT, MASK WITH CO2 MONITORING LINE FDA UDI
- Generic Name
- Rebreathing oxygen face mask FDA UDI
- Device Name
- SENTRI INTERSURGICAL ECOLITE, ADULT, MASK WITH CO2 MONITORING LINE FOR M/S CAPNOGRAPHY, FILTER AND TUBE, 2.1M FDA UDI
- Model / Reference
- 1143017 FDA UDI
- Description
- SENTRI INTERSURGICAL ECOLITE, ADULT, MASK WITH CO2 MONITORING LINE FOR M/S CAPNOGRAPHY, FILTER AND TUBE, 2.1M FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05030267157686 FDA UDI
- 510(k) Number
- K122075 FDA UDI
- FDA Product Code
- CCK FDA UDI
- GMDN Term
- Rebreathing oxygen face mask 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
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Rebreathing oxygen face mask
Sentri Intersurgical Ecolite, Adult, Mask With Co2 Monitoring Line by Intersurgical Incorporated — Class II — FDA UDI — listed in FDA GUDID
Similar devices
Also classified as Rebreathing oxygen face mask.
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- Mask — Beijing Rongrui-Century Science & Technology Co. , Ltd. · Class IIa
- AMARA MASK WITH RS FRAME AND HEADGEAR LARGE, INTL — Respironics Inc. · Class IIa
- ClasStar, GanzGesMask, NIV, AAV, L — Drägerwerk AG & Co. KGaA · Class IIa
- Venticaire Lite — FLEXICARE MEDICAL LIMITED · Class I
- Oro-Nasal Mask — HANS RUDOLPH, INC. · Class IIa
Cleared under the same submission
K122075 also covers:
- GAS MONITORING LINE 1.2MM ID, F LUER LOCK/M LUER LOCK, 1.8M — Intersurgical Incorporated
- GAS MONITORING LINE, 1.2MM ID, MALE/MALE LUER LOCK, 3M — Intersurgical Incorporated
- MONITORING LINE 1.8M, MALE - MALE LUER LOCK CONNECTORS — Intersurgical Incorporated
- PVC MONITORING LINE WITH MALE/MALE LUER LOCK CONNECTORS 3.0M — Intersurgical Incorporated
- SENTRI INTERSURGICAL ECOLITE, ADULT, MASK WITH CO2 MONITORING LINE, FILTER AND TUBE — Intersurgical Incorporated
- SENTRI, ADULT, NASAL CANNULA WITH CURVED PRONGS, CO2 MONITORING LINE — Intersurgical Incorporated
- SENTRI, INFANT, NASAL CANNULA WITH CURVED PRONGS, CO2 MONITORING LINE — Intersurgical Incorporated
- SENTRI, PAEDIATRIC, NASAL CANNULA WITH CURVED PRONGS, CO2 MONITORING LINE — Intersurgical Incorporated
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
- Intersurgical Incorporated
Sources (1)
- FDA UDI f73f05b7-41a3-4e48-b190-420285d7593e 35 fields · synced Jun 8, 2026