FDA UDI
In Commercial Distribution
🇺🇸 United States
HUDSON RCI
DI: 04026704595594
·
Model: IPN042775
·
TELEFLEX INCORPORATED
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
100
Basic Information
- Brand Name
- HUDSON RCI
- Primary DI
- 04026704595594
- Version / Model
- IPN042775
- Catalog Number
- 1765
- Company Name
- TELEFLEX INCORPORATED
- Labeler DUNS
- 002348191
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 100
- Record Status
- Published
- Publish Date
- 2018-09-15
- Public Version
- 2
- Public Version Date
- 2020-02-21
- Public Version Status
- Update
- Public Device Record Key
- 5cd2d502-e7f8-40ef-a6a4-2ddf18ec347c
Device Description
Neonatal Pressure Line Tee
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
- 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
- No
- 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 |
|---|---|---|---|---|
| BYX | TUBING, PRESSURE AND ACCESSORIES | Anesthesiology | 868.5860 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61834 | Breathing circuit gas-sampling/monitoring set | A collection of non-sterile devices intended to be integrated within a breathing circuit to enable interface of gases between the breathing circuit and a respiratory monitoring device for sampling the patient's expired gas for measurements of pressure, flow and/or gas analysis [e.g., end-tidal carbon dioxide (EtCO2) concentration]. It includes both a tube/mask breathing circuit connector with sampling ports (sometimes referred to as a spirometry sensor) and gas-sampling/monitoring respiratory tubing; no electronic devices are included. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 24026704595598 | GS1 | Case | 1 | Not in Commercial Distribution | 2019-09-30 |
| Primary | 04026704595594 | GS1 | ||||
| Unit of Use | 34026704595595 | GS1 |
Customer Contacts
- Phone
- +1(919)544-8000
- [email protected]