LoopView®
GUDID 16975339622128
LoopView®, Single-Use Digital Flexible Bronchoscope, B38
MacroLux Medical Technology Co., Ltd.
Flexible video bronchoscope, single-use Flexible video bronchoscope, single-use Flexible video bronchoscope, single-use Flexible video bronchoscope, single-use Flexible video bronchoscope, single-use Flexible video bronchoscope, single-use Flexible video bronchoscope, single-use Flexible video bronchoscope, single-use Flexible video bronchoscope, single-use Flexible video bronchoscope, single-use Flexible video bronchoscope, single-use Flexible video bronchoscope, single-use Flexible video bronchoscope, single-use Flexible video bronchoscope, single-use Flexible video bronchoscope, single-use Flexible video bronchoscope, single-use Flexible video bronchoscope, single-use| Primary Device ID | 16975339622128 |
| NIH Device Record Key | b4b91699-e0fc-45d2-847e-4b43224a8438 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | LoopView® |
| Version Model Number | B38 |
| Company DUNS | 723490133 |
| Company Name | MacroLux Medical Technology Co., Ltd. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Unsafe |
| 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 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 06975339622121 [Primary] |
| GS1 | 16975339622128 [Package] Contains: 06975339622121 Package: Box [5 Units] In Commercial Distribution |
| GS1 | 26975339622125 [Package] Package: Case [2 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K233779
FDA Product Code
| EOQ | Bronchoscope (Flexible Or Rigid) |
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 | 2024-04-23 |
| Device Publish Date | 2024-04-15 |
On-Brand Devices [LoopView®]
| 16975339622128 | LoopView®, Single-Use Digital Flexible Bronchoscope, B38 |
| 16975339622234 | LoopView®, Single-Use Digital Flexible Bronchoscope, B58-CG |
| 16975339622227 | LoopView®, Single-Use Digital Flexible Bronchoscope, B58-C |
| 16975339622210 | LoopView®, Single-Use Digital Flexible Bronchoscope, B58-G |
| 16975339622203 | LoopView®, Single-Use Digital Flexible Bronchoscope, B58 |
| 16975339622197 | LoopView®, Single-Use Digital Flexible Bronchoscope, B50-CG |
| 16975339622180 | LoopView®, Single-Use Digital Flexible Bronchoscope, B50-C |
| 16975339622173 | LoopView®, Single-Use Digital Flexible Bronchoscope, B50-G |
| 16975339622166 | LoopView®, Single-Use Digital Flexible Bronchoscope, B50 |
| 16975339622159 | LoopView®, Single-Use Digital Flexible Bronchoscope, B38-CG |
| 16975339622142 | LoopView®, Single-Use Digital Flexible Bronchoscope, B38-C |
| 16975339622135 | LoopView®, Single-Use Digital Flexible Bronchoscope, B38-G |
Trademark Results [LoopView]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 LOOPVIEW 74427919 not registered Dead/Abandoned |
AT&T CORP. 1993-08-23 |
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