FDA UDI
In Commercial Distribution
🇺🇸 United States
Resp-O2 Vortex 72 Closed Suction Tracheal Catheter, 10 FR (3.3 mm),30.5 cm/12 in
DI: 00840117344167
·
Model: 31014
·
Dynarex Corporation
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
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Basic Information
- Brand Name
- Resp-O2 Vortex 72 Closed Suction Tracheal Catheter, 10 FR (3.3 mm),30.5 cm/12 in
- Primary DI
- 00840117344167
- Version / Model
- 31014
- Company Name
- Dynarex Corporation
- Labeler DUNS
- 008124539
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-01-05
- Public Version
- 1
- Public Version Date
- 2026-01-13
- Public Version Status
- New
- Public Device Record Key
- abb8f561-8b1b-4f1a-8e93-eca579306cb9
Device Description
Double Swivel Elbow (DSE), Tracheal, Adult/Pediatric CONTENTS: 1. Closed Suction Catheter (Adult/Pediatric), 1. MDI Adaptor, 1. 15 mm x 22 mm Flex Tube, 1. Trach Wedge 1. Change of Day Sticker
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| BSY | Catheters, Suction, Tracheobronchial | Anesthesiology | 868.6810 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 34041 | Tracheobronchial suction/insufflation catheter, single-lumen | A sterile flexible tube designed for periodic tracheal and pharyngeal mucus aspiration and inflation of the lungs with a flow of gas from its distal tip. It consists of a single lumen tube for alternating suction and insufflation. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00840117344167 | GS1 | ||||
| Package | 00840117343993 | GS1 | Box | 10 | In Commercial Distribution | |
| Package | 00840117343832 | GS1 | Case | 2 | In Commercial Distribution |