Identity
- Trade Name
- Resp-O2 Single Suction Catheter, 12 FR, Sterile FDA UDI
- Generic Name
- Airway suction catheter FDA UDI
- Device Name
- Sterile-EO, Adult Graduated Catheter, Control Valve, Coil Packed FDA UDI
- Model / Reference
- 32003 FDA UDI
- Description
- Sterile-EO, Adult Graduated Catheter, Control Valve, Coil Packed FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840117308992 FDA UDI
- FDA Product Code
- BSY FDA UDI
- GMDN Term
- Airway suction catheter 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
Yes
FDA UDI
Category: Airway suction catheter
Resp-O2 Single Suction Catheter, 12 FR, Sterile by Dynarex Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Airway suction catheter.
- AirLife™ — Airlife, Inc. · Class I
- Closed Suction Catheters — Ningbo Xinwell Medical Technology Co., Ltd. · Class I
- Closed Suction Catheters — Ningbo Xinwell Medical Technology Co., Ltd. · Class I
- Novo Surgical Inc. — NOVO SURGICAL, INC. · Class I
- Novo Surgical Inc. — NOVO SURGICAL, INC. · Class I
- Little Sucker Standard TP — Neotech Products LLC · Class II
- Closed Suction Catheters — Ningbo Xinwell Medical Technology Co., Ltd. · Class I
- Novo Surgical Inc. — NOVO SURGICAL, 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Dynarex Corp.
Sources (1)
- FDA UDI 13572e82-1658-49e3-b4ef-b987b68d2a4e 33 fields · synced Jun 1, 2026