FDA UDI
Not in Commercial Distribution
🇺🇸 United States
HUDSON RCI
DI: 34026704659068
·
Model: IPN913701
·
TELEFLEX INCORPORATED
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
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Basic Information
- Brand Name
- HUDSON RCI
- Primary DI
- 34026704659068
- Version / Model
- IPN913701
- Catalog Number
- 1686
- Company Name
- TELEFLEX INCORPORATED
- Labeler DUNS
- 002348191
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-10-28
- Public Version
- 4
- Public Version Date
- 2025-08-04
- Public Version Status
- Update
- Public Device Record Key
- 51c7251d-a13f-48c8-8cd9-cee753ea5408
- Distribution End Date
- 2025-08-01
Device Description
INFANT NASAL CPAP SYSTEM,SIZE NO 2
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
- 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 | 44026704659065 | GS1 | Case | 10 | Not in Commercial Distribution | 2025-08-01 |
| Primary | 34026704659068 | GS1 | ||||
| Previous | 14026704659064 | GS1 |
Customer Contacts
- Phone
- +1(919)544-8000
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K871157 | 000 |