Epi-Max™ Epistaxis Procedure Pack 60-402
GUDID 34063107101428
Size: 97 mm Length; Type: Anterior/Posterior
Boston Medical Products, Inc.
General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use Nasal haemostatic balloon Nasal haemostatic balloon Nasal haemostatic balloon Nasal haemostatic balloon Nasal haemostatic balloon Nasal haemostatic balloon Nasal haemostatic balloon Nasal haemostatic balloon Nasal haemostatic balloon Nasal haemostatic balloon Nasal haemostatic balloon Nasal haemostatic balloon Nasal haemostatic balloon Nasal haemostatic balloon Nasal haemostatic balloon Nasal haemostatic balloon Nasal haemostatic balloon| Primary Device ID | 34063107101428 |
| NIH Device Record Key | df4a2eb1-45d1-4fc1-ac77-459a9f7f32b9 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Epi-Max™ Epistaxis Procedure Pack |
| Version Model Number | 60-402 |
| Catalog Number | 60-402 |
| Company DUNS | 131855157 |
| Company Name | Boston Medical Products, Inc. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Safe |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | 1-800-433-2674 |
| info@bosmed.com | |
| Phone | 1-800-433-2674 |
| info@bosmed.com | |
| Phone | 1-800-433-2674 |
| info@bosmed.com | |
| Phone | 1-800-433-2674 |
| info@bosmed.com | |
| Phone | 1-800-433-2674 |
| info@bosmed.com | |
| Phone | 1-800-433-2674 |
| info@bosmed.com | |
| Phone | 1-800-433-2674 |
| info@bosmed.com | |
| Phone | 1-800-433-2674 |
| info@bosmed.com | |
| Phone | 1-800-433-2674 |
| info@bosmed.com | |
| Phone | 1-800-433-2674 |
| info@bosmed.com | |
| Phone | 1-800-433-2674 |
| info@bosmed.com | |
| Phone | 1-800-433-2674 |
| info@bosmed.com | |
| Phone | 1-800-433-2674 |
| info@bosmed.com | |
| Phone | 1-800-433-2674 |
| info@bosmed.com | |
| Phone | 1-800-433-2674 |
| info@bosmed.com | |
| Phone | 1-800-433-2674 |
| info@bosmed.com | |
| Phone | 1-800-433-2674 |
| info@bosmed.com | |
| Phone | 1-800-433-2674 |
| info@bosmed.com | |
| Phone | 1-800-433-2674 |
| info@bosmed.com | |
| Phone | 1-800-433-2674 |
| info@bosmed.com | |
| Phone | 1-800-433-2674 |
| info@bosmed.com | |
| Phone | 1-800-433-2674 |
| info@bosmed.com | |
| Phone | 1-800-433-2674 |
| info@bosmed.com | |
| Phone | 1-800-433-2674 |
| info@bosmed.com | |
| Phone | 1-800-433-2674 |
| info@bosmed.com | |
| Phone | 1-800-433-2674 |
| info@bosmed.com | |
| Phone | 1-800-433-2674 |
| info@bosmed.com | |
| Phone | 1-800-433-2674 |
| info@bosmed.com | |
| Phone | 1-800-433-2674 |
| info@bosmed.com | |
| Phone | 1-800-433-2674 |
| info@bosmed.com | |
| Phone | 1-800-433-2674 |
| info@bosmed.com | |
| Phone | 1-800-433-2674 |
| info@bosmed.com | |
| Phone | 1-800-433-2674 |
| info@bosmed.com |
Device Dimensions
| Length | 97 Millimeter |
| Length | 97 Millimeter |
| Length | 97 Millimeter |
| Length | 97 Millimeter |
| Length | 97 Millimeter |
| Length | 97 Millimeter |
| Length | 97 Millimeter |
| Length | 97 Millimeter |
| Length | 97 Millimeter |
| Length | 97 Millimeter |
| Length | 97 Millimeter |
| Length | 97 Millimeter |
| Length | 97 Millimeter |
| Length | 97 Millimeter |
| Length | 97 Millimeter |
| Length | 97 Millimeter |
| Length | 97 Millimeter |
| Length | 97 Millimeter |
| Length | 97 Millimeter |
| Length | 97 Millimeter |
| Length | 97 Millimeter |
| Length | 97 Millimeter |
| Length | 97 Millimeter |
| Length | 97 Millimeter |
| Length | 97 Millimeter |
| Length | 97 Millimeter |
| Length | 97 Millimeter |
| Length | 97 Millimeter |
| Length | 97 Millimeter |
| Length | 97 Millimeter |
| Length | 97 Millimeter |
| Length | 97 Millimeter |
| Length | 97 Millimeter |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 14063107101424 [Primary] |
| GS1 | 34063107101428 [Package] Contains: 14063107101424 Package: Carton [1 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K972076
FDA Product Code
| EMX | Balloon, Epistaxis |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-10-07 |
| Device Publish Date | 2022-09-29 |
On-Brand Devices [Epi-Max™ Epistaxis Procedure Pack]
| EBES60402L0 | Size: 120 mm Length; Type: Anterior/Posterior |
| EBES604020 | Size: 97 mm Length; Type: Anterior/Posterior |
| 34063107101435 | Size: 120 mm Length; Type: Anterior/Posterior |
| 34063107101428 | Size: 97 mm Length; Type: Anterior/Posterior |
Trademark Results [Epi-Max]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 EPI-MAX 97783900 not registered Live/Pending |
Adcock Ingram Intellectual Property (Proprietary) Limited 2023-02-07 |
 EPI-MAX 86933932 5169585 Live/Registered |
Genop Holdings Proprietary Limited 2016-03-09 |
 EPI-MAX 78432110 3124494 Dead/Cancelled |
Greystone Medical Group, Inc. 2004-06-09 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.