Identity
- Trade Name
- RUSCH FDA UDI
- Generic Name
- Nasal haemostatic balloon FDA UDI
- Device Name
- RUSCH® Fox Post-Nasal Tube With 10cc Syringe, Red Rubber, Soft latex balloon FDA UDI
- Model / Reference
- IPN044985 FDA UDI
- Description
- RUSCH® Fox Post-Nasal Tube With 10cc Syringe, Red Rubber, Soft latex balloon FDA UDI
Identifiers
- Catalog Number
- 568000 FDA UDI
- Primary DI / UDI-DI
- 04026704543953 FDA UDI
- FDA Product Code
- EMX FDA UDI
- GMDN Term
- Nasal haemostatic balloon FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 874.4100 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
Yes
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Nasal haemostatic balloon
Rusch by Teleflex Incorporated — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Nasal haemostatic balloon.
- EPISTAX BALLOON CATHETER — Summit Medical, LLC · Class I
- RELIEVA SPIN — ACCLARENT, INC. · Class I
- RELIEVA SPINPLUS — ACCLARENT, INC. · Class I
- Epistax Balloon Catheter — Summit Medical, LLC · Class I
- Epistat® — MEDTRONIC XOMED, INC. · Class I
- Invotec Post Stat — Invotec International, Inc. · Class I
- RELIEVA SPINPLUS — ACCLARENT, INC. · Class I
- Rhino-Pak 75mm — Mar-Med Co. · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Teleflex Incorporated
Sources (1)
- FDA UDI 080b290b-579b-4603-87dc-2df43d0f624d 35 fields · synced May 30, 2026