LaparoVue
GUDID 20815198012247
LaparoVue Visibility System
Buffalo Filter
Endoscopic antifog solution| Primary Device ID | 20815198012247 |
| NIH Device Record Key | b97bb027-a053-4c36-b7a6-bd359555b4b9 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | LaparoVue |
| Version Model Number | LAPVUE01 |
| Company DUNS | 787855907 |
| Company Name | Buffalo Filter |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| 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 | 716-835-7000 |
| bf.smoke.info@filtrationgroup.com | |
| Phone | 716-835-7000 |
| bf.smoke.info@filtrationgroup.com | |
| Phone | 716-835-7000 |
| bf.smoke.info@filtrationgroup.com | |
| Phone | 716-835-7000 |
| bf.smoke.info@filtrationgroup.com | |
| Phone | 716-835-7000 |
| bf.smoke.info@filtrationgroup.com | |
| Phone | 716-835-7000 |
| bf.smoke.info@filtrationgroup.com | |
| Phone | 716-835-7000 |
| bf.smoke.info@filtrationgroup.com | |
| Phone | 716-835-7000 |
| bf.smoke.info@filtrationgroup.com | |
| Phone | 716-835-7000 |
| bf.smoke.info@filtrationgroup.com | |
| Phone | 716-835-7000 |
| bf.smoke.info@filtrationgroup.com | |
| Phone | 716-835-7000 |
| bf.smoke.info@filtrationgroup.com | |
| Phone | 716-835-7000 |
| bf.smoke.info@filtrationgroup.com | |
| Phone | 716-835-7000 |
| bf.smoke.info@filtrationgroup.com | |
| Phone | 716-835-7000 |
| bf.smoke.info@filtrationgroup.com | |
| Phone | 716-835-7000 |
| bf.smoke.info@filtrationgroup.com | |
| Phone | 716-835-7000 |
| bf.smoke.info@filtrationgroup.com | |
| Phone | 716-835-7000 |
| bf.smoke.info@filtrationgroup.com | |
| Phone | 716-835-7000 |
| bf.smoke.info@filtrationgroup.com |
Operating and Storage Conditions
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 104 Degrees Fahrenheit |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00815198012243 [Primary] |
| GS1 | 10815198012240 [Package] Contains: 00815198012243 Package: Case [3 Units] In Commercial Distribution |
| GS1 | 20815198012247 [Package] Contains: 00815198012243 Package: Case [10 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K150569
FDA Product Code
| GCJ | Laparoscope, General & Plastic Surgery |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2018-07-10 |
| Device Publish Date | 2016-09-23 |
Devices Manufactured by Buffalo Filter
| 10815198011045 - Buffalo Filter | 2022-04-22 Reducer Fitting 1-3/8" to 3/8" |
| 10815198011069 - Buffalo Filter | 2022-04-22 Laser Resistant Wand with Sponge Guard |
| 10815198011175 - Buffalo Filter | 2022-04-22 Sponge Guard |
| 10815198011311 - Buffalo Filter | 2022-04-22 Reducer Fitting 7/8" to 1/4" with 2" cuff |
| 20815198012636 - Cooper Surgical | 2022-04-22 Smoke Ecavuator Pre-Filter |
| 10851136002287 - Buffalo Filter | 2022-04-22 Reducer Fitting 7/8" to 1/4" |
| 10851136002317 - LaseAdapt | 2022-04-22 Reusable Clips |
| 10851136002768 - Buffalo Filter | 2022-04-22 Laser Resistant Wand with Sponge Guard |
Trademark Results [LaparoVue]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 LAPAROVUE 86347262 4923571 Live/Registered |
Buffalo Filter LLC 2014-07-24 |
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