Identity
- Trade Name
- Epi-Max™ Epistaxis Procedure Pack FDA UDI
- Generic Name
- Nasal haemostatic balloon FDA UDI
- Device Name
- Size: 120 mm Length; Type: Anterior/Posterior FDA UDI
- Model / Reference
- 60-402L FDA UDI
- Description
- Size: 120 mm Length; Type: Anterior/Posterior FDA UDI
Identifiers
- Catalog Number
- 60-402L FDA UDI
- Primary DI / UDI-DI
- 14063107101431 FDA UDI
- 510(k) Number
- K972076 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
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Safe FDA UDI
Dimensions & Sizes
- Size
- Length — 120 Millimeter FDA UDI
Category: Nasal haemostatic balloon
Epi-Max™ Epistaxis Procedure Pack by Boston Medical Products, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K972076 also covers:
- Epi-Max™ Epistaxis Catheter — Boston Medical Products, Inc.
- Epi-Max™ Epistaxis Catheter — Boston Medical Products, Inc.
- Epi-Max™ Epistaxis Procedure Pack — Boston Medical Products, Inc.
- Epi-Max™ Epistaxis Procedure Pack — Boston Medical Products, Inc.
- Epi-Max™ Epistaxis Procedure Pack — Boston Medical Products, Inc.
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
- Boston Medical Products, Inc.
Sources (1)
- FDA UDI 344df339-40c5-4d68-865a-b6a9319bb46c 38 fields · synced Jun 9, 2026