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Resp-O2 Closed Suction Tracheostomy Catheter, Sterile
FDA UDIClass I (US FDA UDI)
Identity
- Trade Name
- Resp-O2 Closed Suction Tracheostomy Catheter, Sterile FDA UDI
- Generic Name
- Closed-suction breathing circuit connector/switch FDA UDI
- Device Name
- Adult, Double Swivel Elbow (DSE), Diameter (5.3mm (16FR), Length ( Tracheostomy 30.2cm / 12in. CONTENTS: Catheter, MDI Port, 15mm x 22mm Flex Tube, Change of Day. FDA UDI
- Model / Reference
- 31013 FDA UDI
- Description
- Adult, Double Swivel Elbow (DSE), Diameter (5.3mm (16FR), Length ( Tracheostomy 30.2cm / 12in. CONTENTS: Catheter, MDI Port, 15mm x 22mm Flex Tube, Change of Day. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840117319486 FDA UDI
- FDA Product Code
- BSY FDA UDI
- GMDN Term
- Closed-suction breathing circuit connector/switch FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 868.6810 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Closed-suction breathing circuit connector/switch
Resp-O2 Closed Suction Tracheostomy Catheter, Sterile by Dynarex Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Closed-suction breathing circuit connector/switch.
- Deluxe Closed Suction System — SUNSET HEALTHCARE SOLUTIONS, Inc. · Class I
- Deluxe Closed Suction System — SUNSET HEALTHCARE SOLUTIONS, Inc. · Class I
- Suction Tubing — SUNSET HEALTHCARE SOLUTIONS, Inc. · Class I
- Tracheostomy and Suction Accessory — SUNSET HEALTHCARE SOLUTIONS, Inc. · Class I
- Closed Suction — SUNSET HEALTHCARE SOLUTIONS, Inc. · Class I
- Suction Kit — SUNSET HEALTHCARE SOLUTIONS, Inc. · Class I
- Closed Suction — SUNSET HEALTHCARE SOLUTIONS, Inc. · Class I
- Deluxe Closed Suction System 72hr — SUNSET HEALTHCARE SOLUTIONS, Inc. · Class I
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 I | Pending data |
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Manufacturer
- Manufacturer
- Dynarex Corp.
Sources (1)
- FDA UDI 520863b2-4944-4696-8f8c-bcf0e2c5304b 33 fields · synced May 30, 2026