CELLO™, Balloon Guide Catheter
GUDID 14544050120743
The CELLO Balloon Guide Catheter is indicated for use in facilitating the insertion and guidance of intravascular catheters into a selected blood vessel in the peripheral and neuro vasculature systems. The balloon provides temporary vascular occlusion during these and other angiographic procedures.
FUJI SYSTEMS CORPORATION
Intravascular occluding balloon catheter, image-guided| Primary Device ID | 14544050120743 |
| NIH Device Record Key | f4ae9477-0b83-46c2-9c0e-6acf40b7eddf |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CELLO™, Balloon Guide Catheter |
| Version Model Number | 1610590 |
| Company DUNS | 715919973 |
| Company Name | FUJI SYSTEMS CORPORATION |
| 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 | true |
| 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 Dimensions
| Device Size Text, specify | 0 |
| Outer Diameter | 3 Millimeter |
| Catheter Inner Diameter | 2.15 Millimeter |
| Shaft Length | 920 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 3 Millimeter |
| Catheter Inner Diameter | 2.15 Millimeter |
| Shaft Length | 920 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 3 Millimeter |
| Catheter Inner Diameter | 2.15 Millimeter |
| Shaft Length | 920 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 3 Millimeter |
| Catheter Inner Diameter | 2.15 Millimeter |
| Shaft Length | 920 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 3 Millimeter |
| Catheter Inner Diameter | 2.15 Millimeter |
| Shaft Length | 920 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 3 Millimeter |
| Catheter Inner Diameter | 2.15 Millimeter |
| Shaft Length | 920 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 3 Millimeter |
| Catheter Inner Diameter | 2.15 Millimeter |
| Shaft Length | 920 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 3 Millimeter |
| Catheter Inner Diameter | 2.15 Millimeter |
| Shaft Length | 920 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 3 Millimeter |
| Catheter Inner Diameter | 2.15 Millimeter |
| Shaft Length | 920 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 3 Millimeter |
| Catheter Inner Diameter | 2.15 Millimeter |
| Shaft Length | 920 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 3 Millimeter |
| Catheter Inner Diameter | 2.15 Millimeter |
| Shaft Length | 920 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 3 Millimeter |
| Catheter Inner Diameter | 2.15 Millimeter |
| Shaft Length | 920 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 3 Millimeter |
| Catheter Inner Diameter | 2.15 Millimeter |
| Shaft Length | 920 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 3 Millimeter |
| Catheter Inner Diameter | 2.15 Millimeter |
| Shaft Length | 920 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 3 Millimeter |
| Catheter Inner Diameter | 2.15 Millimeter |
| Shaft Length | 920 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 3 Millimeter |
| Catheter Inner Diameter | 2.15 Millimeter |
| Shaft Length | 920 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 3 Millimeter |
| Catheter Inner Diameter | 2.15 Millimeter |
| Shaft Length | 920 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 3 Millimeter |
| Catheter Inner Diameter | 2.15 Millimeter |
| Shaft Length | 920 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 3 Millimeter |
| Catheter Inner Diameter | 2.15 Millimeter |
| Shaft Length | 920 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 3 Millimeter |
| Catheter Inner Diameter | 2.15 Millimeter |
| Shaft Length | 920 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 3 Millimeter |
| Catheter Inner Diameter | 2.15 Millimeter |
| Shaft Length | 920 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 3 Millimeter |
| Catheter Inner Diameter | 2.15 Millimeter |
| Shaft Length | 920 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 3 Millimeter |
| Catheter Inner Diameter | 2.15 Millimeter |
| Shaft Length | 920 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 3 Millimeter |
| Catheter Inner Diameter | 2.15 Millimeter |
| Shaft Length | 920 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 3 Millimeter |
| Catheter Inner Diameter | 2.15 Millimeter |
| Shaft Length | 920 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 3 Millimeter |
| Catheter Inner Diameter | 2.15 Millimeter |
| Shaft Length | 920 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 3 Millimeter |
| Catheter Inner Diameter | 2.15 Millimeter |
| Shaft Length | 920 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 3 Millimeter |
| Catheter Inner Diameter | 2.15 Millimeter |
| Shaft Length | 920 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 3 Millimeter |
| Catheter Inner Diameter | 2.15 Millimeter |
| Shaft Length | 920 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 3 Millimeter |
| Catheter Inner Diameter | 2.15 Millimeter |
| Shaft Length | 920 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 3 Millimeter |
| Catheter Inner Diameter | 2.15 Millimeter |
| Shaft Length | 920 Millimeter |
Operating and Storage Conditions
| Storage Environment Temperature | Between 0 Degrees Celsius and 54 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry, dark place |
| Storage Environment Temperature | Between 0 Degrees Celsius and 54 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry, dark place |
| Storage Environment Temperature | Between 0 Degrees Celsius and 54 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry, dark place |
| Storage Environment Temperature | Between 0 Degrees Celsius and 54 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry, dark place |
| Storage Environment Temperature | Between 0 Degrees Celsius and 54 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry, dark place |
| Storage Environment Temperature | Between 0 Degrees Celsius and 54 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry, dark place |
| Storage Environment Temperature | Between 0 Degrees Celsius and 54 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry, dark place |
| Storage Environment Temperature | Between 0 Degrees Celsius and 54 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry, dark place |
| Storage Environment Temperature | Between 0 Degrees Celsius and 54 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry, dark place |
| Storage Environment Temperature | Between 0 Degrees Celsius and 54 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry, dark place |
| Storage Environment Temperature | Between 0 Degrees Celsius and 54 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry, dark place |
| Storage Environment Temperature | Between 0 Degrees Celsius and 54 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry, dark place |
| Storage Environment Temperature | Between 0 Degrees Celsius and 54 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry, dark place |
| Storage Environment Temperature | Between 0 Degrees Celsius and 54 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry, dark place |
| Storage Environment Temperature | Between 0 Degrees Celsius and 54 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry, dark place |
| Storage Environment Temperature | Between 0 Degrees Celsius and 54 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry, dark place |
| Storage Environment Temperature | Between 0 Degrees Celsius and 54 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry, dark place |
| Storage Environment Temperature | Between 0 Degrees Celsius and 54 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry, dark place |
| Storage Environment Temperature | Between 0 Degrees Celsius and 54 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry, dark place |
| Storage Environment Temperature | Between 0 Degrees Celsius and 54 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry, dark place |
| Storage Environment Temperature | Between 0 Degrees Celsius and 54 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry, dark place |
| Storage Environment Temperature | Between 0 Degrees Celsius and 54 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry, dark place |
| Storage Environment Temperature | Between 0 Degrees Celsius and 54 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry, dark place |
| Storage Environment Temperature | Between 0 Degrees Celsius and 54 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry, dark place |
| Storage Environment Temperature | Between 0 Degrees Celsius and 54 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry, dark place |
| Storage Environment Temperature | Between 0 Degrees Celsius and 54 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry, dark place |
| Storage Environment Temperature | Between 0 Degrees Celsius and 54 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry, dark place |
| Storage Environment Temperature | Between 0 Degrees Celsius and 54 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry, dark place |
| Storage Environment Temperature | Between 0 Degrees Celsius and 54 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry, dark place |
| Storage Environment Temperature | Between 0 Degrees Celsius and 54 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry, dark place |
| Storage Environment Temperature | Between 0 Degrees Celsius and 54 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry, dark place |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04544050093491 [Previous] |
| GS1 | 04544050120746 [Primary] |
| GS1 | 14544050120743 [Package] Contains: 04544050120746 Package: [1 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K120781
FDA Product Code
| DQY | Catheter, Percutaneous |
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 | 2022-01-26 |
| Device Publish Date | 2022-01-18 |
On-Brand Devices [CELLO™, Balloon Guide Catheter]
| 04544050093491 | The CELLO Balloon Guide Catheter is indicated for use in facilitating the insertion and guidance |
| 04544050093484 | The CELLO Balloon Guide Catheter is indicated for use in facilitating the insertion and guidance |
| 04544050093460 | The CELLO Balloon Guide Catheter is indicated for use in facilitating the insertion and guidance |
| 04544050093446 | The CELLO Balloon Guide Catheter is indicated for use in facilitating the insertion and guidance |
| 14544050120743 | The CELLO Balloon Guide Catheter is indicated for use in facilitating the insertion and guidance |
| 14544050120736 | The CELLO Balloon Guide Catheter is indicated for use in facilitating the insertion and guidance |
| 04544050120722 | The CELLO Balloon Guide Catheter is indicated for use in facilitating the insertion and guidance |
| 04544050120715 | The CELLO Balloon Guide Catheter is indicated for use in facilitating the insertion and guidance |
Trademark Results [CELLO]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CELLO 98600476 not registered Live/Pending |
BLAYDON UK LIMITED 2024-06-13 |
 CELLO 97762442 not registered Live/Pending |
NONA RESEARCH FOUNDATION, INC. 2023-01-20 |
 CELLO 97476505 not registered Live/Pending |
Cellorama LLC 2022-06-27 |
 CELLO 97425552 not registered Live/Pending |
Powerplay GmbH 2022-05-24 |
 CELLO 90502197 not registered Live/Pending |
Exo Imaging, Inc. 2021-02-01 |
 CELLO 88726554 not registered Live/Pending |
Cello Plastic Industrial Works 2019-12-13 |
 CELLO 88519996 not registered Live/Pending |
Arthur Schuman, Inc. 2019-07-17 |
 CELLO 88485196 not registered Live/Pending |
AL Bazzaz Group for Trading & Industry Limited 2019-06-23 |
 CELLO 88396362 not registered Live/Pending |
DENTAL FOCUS, L.L.C. 2019-04-22 |
 CELLO 87786888 not registered Dead/Abandoned |
Arthur Schuman, Inc. 2018-02-06 |
 CELLO 86666735 4931339 Live/Registered |
ASIMOV, INC. 2015-06-18 |
 CELLO 86666632 4931328 Live/Registered |
ASIMOV, INC. 2015-06-18 |
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