FDA UDI
In Commercial Distribution
🇺🇸 United States
HUDSON RCI
DI: 04026704390366
·
Model: IPN044454
·
TELEFLEX INCORPORATED
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- HUDSON RCI
- Primary DI
- 04026704390366
- Version / Model
- IPN044454
- Catalog Number
- 41691
- Company Name
- TELEFLEX INCORPORATED
- Labeler DUNS
- 002348191
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-16
- Public Version
- 6
- Public Version Date
- 2022-03-22
- Public Version Status
- Update
- Public Device Record Key
- 663a7590-324a-4c8f-ae45-c0a5cc20bb73
Device Description
INFANT NASAL CPAP CANNULA, SZ 1,INTL
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| BZD | VENTILATOR, NON-CONTINUOUS (RESPIRATOR) | Anesthesiology | 868.5905 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35202 | Nasal oxygen cannula, CPAP | A semi-rigid tube with nasal prongs designed to be inserted into the nostrils of a patient, and held in place with a headstrap, to deliver oxygen (O2) to the patient and provide continuous positive airway pressure (CPAP) from the devices to which it is connected. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 24026704390360 | GS1 | Box | 10 | Not in Commercial Distribution | 2019-09-30 |
| Primary | 04026704390366 | GS1 |
Customer Contacts
- Phone
- +1(919)544-8000
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K871157 | 000 |