Bi-Blade® 2340BB
GUDID 00812480010758
25 Gauge BB Vitreous Cutter,R1+,w 72” Rev Posterior Tubing Set, Sterile, Single Use
MEDICAL INSTRUMENT DEVELOPMENT LABORATORIES, INC.
Vitrectomy system micro-cutting unit Vitrectomy system micro-cutting unit Vitrectomy system micro-cutting unit Vitrectomy system micro-cutting unit Vitrectomy system micro-cutting unit Vitrectomy system micro-cutting unit Vitrectomy system micro-cutting unit Vitrectomy system micro-cutting unit Vitrectomy system micro-cutting unit Vitrectomy system micro-cutting unit Vitrectomy system micro-cutting unit Vitrectomy system micro-cutting unit Vitrectomy system micro-cutting unit Vitrectomy system micro-cutting unit Vitrectomy system micro-cutting unit Vitrectomy system micro-cutting unit Vitrectomy system micro-cutting unit Vitrectomy system micro-cutting unit| Primary Device ID | 00812480010758 |
| NIH Device Record Key | cb8b7fa3-9c7d-4268-8667-4a4219841495 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Bi-Blade® |
| Version Model Number | 2340BB |
| Catalog Number | 2340BB |
| Company DUNS | 790265227 |
| Company Name | MEDICAL INSTRUMENT DEVELOPMENT LABORATORIES, INC. |
| 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 | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | 1(800)929-5227 |
| qa@midlabs.com | |
| Phone | 1(800)929-5227 |
| qa@midlabs.com | |
| Phone | 1(800)929-5227 |
| qa@midlabs.com | |
| Phone | 1(800)929-5227 |
| qa@midlabs.com | |
| Phone | 1(800)929-5227 |
| qa@midlabs.com | |
| Phone | 1(800)929-5227 |
| qa@midlabs.com | |
| Phone | 1(800)929-5227 |
| qa@midlabs.com | |
| Phone | 1(800)929-5227 |
| qa@midlabs.com | |
| Phone | 1(800)929-5227 |
| qa@midlabs.com | |
| Phone | 1(800)929-5227 |
| qa@midlabs.com | |
| Phone | 1(800)929-5227 |
| qa@midlabs.com | |
| Phone | 1(800)929-5227 |
| qa@midlabs.com | |
| Phone | 1(800)929-5227 |
| qa@midlabs.com | |
| Phone | 1(800)929-5227 |
| qa@midlabs.com | |
| Phone | 1(800)929-5227 |
| qa@midlabs.com | |
| Phone | 1(800)929-5227 |
| qa@midlabs.com | |
| Phone | 1(800)929-5227 |
| qa@midlabs.com | |
| Phone | 1(800)929-5227 |
| qa@midlabs.com |
Device Dimensions
| Needle Gauge | 25 Gauge |
| Needle Gauge | 25 Gauge |
| Needle Gauge | 25 Gauge |
| Needle Gauge | 25 Gauge |
| Needle Gauge | 25 Gauge |
| Needle Gauge | 25 Gauge |
| Needle Gauge | 25 Gauge |
| Needle Gauge | 25 Gauge |
| Needle Gauge | 25 Gauge |
| Needle Gauge | 25 Gauge |
| Needle Gauge | 25 Gauge |
| Needle Gauge | 25 Gauge |
| Needle Gauge | 25 Gauge |
| Needle Gauge | 25 Gauge |
| Needle Gauge | 25 Gauge |
| Needle Gauge | 25 Gauge |
| Needle Gauge | 25 Gauge |
| Needle Gauge | 25 Gauge |
Operating and Storage Conditions
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 98 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 98 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 98 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 98 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 98 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 98 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 98 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 98 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 98 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 98 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 98 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 98 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 98 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 98 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 98 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 98 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 98 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 98 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 98 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 98 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 98 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 98 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 98 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 98 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 98 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 98 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 98 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 98 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 98 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 98 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 98 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 98 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 98 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 98 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 98 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 98 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 98 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 98 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 98 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 98 Percent (%) Relative Humidity |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00812480010758 [Primary] |
| GS1 | 10812480010755 [Package] Package: Carton [6 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K153168
FDA Product Code
| HQE | Instrument, Vitreous Aspiration And Cutting, Ac-Powered |
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 | 2018-10-25 |
| Device Publish Date | 2018-09-24 |
On-Brand Devices [Bi-Blade®]
| 10812480011196 | 27 Gauge BB Vitreous Cutter, R3A, w/ 72” Anterior Tubing Set, Sterile, Single Use |
| 10812480011042 | 27 Gauge BB Vitreous Cutter, R4+, w/ 72” Anterior Tubing Set, Sterile, Single Use |
| 10812480011028 | 25 Gauge BB Vitreous Cutter, R1+, w/ 79” Anterior Tubing Set, Sterile, Single Use, 1ea |
| 10812480011011 | 23 Gauge BB Vitreous Cutter, RZ, w/ 72” Anterior Tubing Set, Sterile, Single Use |
| 00812480010871 | 27 Gauge BB Vitreous Cutter, R3A, w 79"/98" UVE Tubing Set, Sterile, Single Use |
| 00812480010864 | 25 Gauge BB Vitreous Cutter, R3A, w 79"/98" UVE Tubing Set, Sterile, Single Use |
| 00812480010857 | 23 Gauge BB Vitreous Cutter, R3A, w 79"/98" UVE Tubing Set, Sterile, Single Use |
| 00812480010840 | 27 Gauge BB Vitreous Cutter, R1, w 79"/98” MID Labs Tubing Set, Sterile, Single Use |
| 00812480010833 | 25 Gauge BB Vitreous Cutter, R1, w/ 79"/98” MID Labs Tubing Set, Sterile, Single Use |
| 00812480010826 | 23 Gauge BB Vitreous Cutter, R1, w/ 79"/98” MID Labs Tubing Set, Sterile, Single Use |
| 00812480010802 | 23 Gauge BB Vitreous Cutter, R3+, w 72” Anterior Tubing Set, Sterile, Single Use |
| 00812480010796 | 27 Gauge BB Vitreous Cutter, RX, w/ 70” Posterior Tubing Set, Sterile, Single Use |
| 00812480010789 | 25 Gauge BB Vitreous Cutter, RX, w/ 70” Posterior Tubing Set, Sterile, Single Use |
| 00812480010772 | 23 Gauge BB Vitreous Cutter, RX, w/ 70” Posterior Tubing Set, Sterile, Single Use |
| 00812480010765 | 27 Gauge BB Vitreous Cutter,R1+,w 72” Rev Posterior Tubing Set, Sterile, Single Use |
| 00812480010758 | 25 Gauge BB Vitreous Cutter,R1+,w 72” Rev Posterior Tubing Set, Sterile, Single Use |
| 00812480010741 | 23 Gauge BB Vitreous Cutter,R1+,w 72” Rev Posterior Tubing Set, Sterile, Single Use |
| 10812480011035 | 27 Gauge BB Vitreous Cutter, 25 psi, Luer Anterior PVC Tubing Set, Sterile, Single Use |
| 00812480011007 | 27 Gauge BB Vitreous Cutter, 20 psi, Luer Anterior PVC Tubing Set, Sterile, Single Use |
Trademark Results [Bi-Blade]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 BI-BLADE 90831673 not registered Live/Pending |
MEDICAL INSTRUMENT DEVELOPMENT LABORATORIES, INC. 2021-07-15 |
 BI-BLADE 86719560 5014836 Live/Registered |
Medical Instrument Development Laboratories, Inc. 2015-08-10 |
 BI-BLADE 74002913 1693218 Dead/Cancelled |
HUGHES SPORTS, INC. 1989-11-16 |
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