FDA UDI
In Commercial Distribution
🇺🇸 United States
HUDSON RCI
DI: 14026704658777
·
Model: IPN029718
·
TELEFLEX INCORPORATED
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- HUDSON RCI
- Primary DI
- 14026704658777
- Version / Model
- IPN029718
- Catalog Number
- 1743
- Company Name
- TELEFLEX INCORPORATED
- Labeler DUNS
- 002348191
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-09-25
- Public Version
- 3
- Public Version Date
- 2024-01-11
- Public Version Status
- Update
- Public Device Record Key
- 2fbbc19c-ce6f-45ff-aa79-28030aacb9e6
Device Description
In-Line NebTee with Valve 22mm O.D. x 18mm I.D. x 22mm I.D.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- 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
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| BZA | CONNECTOR, AIRWAY (EXTENSION) | Anesthesiology | 868.5810 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 42417 | Cardiac sizing catheter | A sterile flexible tube with an inflatable balloon at the distal end designed for use in a patient with a cardiovascular defect wherein accurate measurement of the defect is important to select the appropriately sized occlusion device. It is typically designed to pass over a guidewire and it will have radiopaque marker bands along it distal end to assist in placement using fluoroscopy. It is made of plastic materials and metal [e, g, platinum (Pt) for the bands] and is available in a variety of designs and sizes. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 24026704658774 | GS1 | Case | 30 | In Commercial Distribution | |
| Primary | 14026704658777 | GS1 | ||||
| Previous | 04026704595501 | GS1 |
Customer Contacts
- Phone
- +1(919)544-8000
- [email protected]