AeroClear
GUDID 00858439001774
The kit includes the aerosol evacuator that has a white suction connector attached to tubing that terminates in a beveled end. Inserted on this tubing is a yellow foam seal and a black positioning ring that can both slide along the tubing. A spare larger foam seal and a male connector are also supplied. When surgery is performed in one nasal cavity, the AeroClear is placed in the contralateral cavity and connected to facility suction.
HEMOSTASIS, LLC
Surgical/emergency suction cannula, non-illuminating, single-use| Primary Device ID | 00858439001774 |
| NIH Device Record Key | 8b5b5875-3ea0-416a-ba16-e74acde5e25d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | AeroClear |
| Version Model Number | 9770013 |
| Company DUNS | 801380697 |
| Company Name | HEMOSTASIS, LLC |
| Device Count | 1 |
| DM Exempt | true |
| Pre-market Exempt | true |
| 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
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature. |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00858439001774 [Primary] |
| GS1 | 00858439001781 [Package] Package: Carton [10 Units] In Commercial Distribution |
| GS1 | 00858439001798 [Package] Package: Carton [2 Units] In Commercial Distribution |
FDA Product Code
| JOL | Catheter And Tip, Suction |
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 | 2020-12-08 |
| Device Publish Date | 2020-11-30 |
Devices Manufactured by HEMOSTASIS, LLC
| 00858439001880 - PosiSep X2 0.7" x 1.7" | 2021-05-11 PosiSep X2 devices are patient-comfortable sponges manufactured from naturally occurring Chitosan polymers. PosiSep X2 devices e |
| 00858439001910 - PosiSep X2 0.8" x 2.3" | 2021-05-11 PosiSep X2 devices are patient-comfortable sponges manufactured from naturally occurring Chitosan polymers. PosiSep X2 devices e |
| 00858439001989 - NexStat 1gm | 2021-05-11 The Hemostasis NexStat topical hemostat powder is a sterile, topical wound dressing comprised of plant based polysaccharides. Th |
| 00858439001774 - AeroClear | 2020-12-08The kit includes the aerosol evacuator that has a white suction connector attached to tubing that terminates in a beveled end. Inserted on this tubing is a yellow foam seal and a black positioning ring that can both slide along the tubing. A spare larger foam seal and a male connector are also supplied. When surgery is performed in one nasal cavity, the AeroClear is placed in the contralateral cavity and connected to facility suction. |
| 00858439001774 - AeroClear | 2020-12-08 The kit includes the aerosol evacuator that has a white suction connector attached to tubing that terminates in a beveled end. I |
| 00858439001705 - ExcelArrest XT 2x2 Hemostatic Patch | 2020-11-30 ExcelArrest XT (EAXT) is a single use, sterile, dry chitosan-based foam hemostat. EAXT is offered as compressed foam pads in ste |
| 00858439001293 - NexStat Plus 2gm | 2020-10-08 The Hemostasis NexStat Plus topical hemostat powder is a sterile, topical wound dressing comprised of plant based polysaccharide |
| 00858439001408 - NexStat Plus 3gm | 2020-10-08 The hemostasis NexStat Plus topical hemostat powder is a sterile, topical wound dressing comprised of plant based polysaccharide |
| 00858439001439 - NexStat | 2020-10-08 The Hemostasis NexStat topical hemostat powder is a sterile, topical wound dressing comprised of plant based polysaccharides. Th |
Trademark Results [AeroClear]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 AEROCLEAR 98365337 not registered Live/Pending |
Aeroclear 2024-01-19 |
 AEROCLEAR 90127389 not registered Live/Pending |
Hemostasis, LLC 2020-08-20 |
 AEROCLEAR 88015362 5852970 Live/Registered |
C.K.S. Packaging, Inc. 2018-06-26 |
 AEROCLEAR 85133176 not registered Dead/Abandoned |
Akzo Nobel Coatings International B.V. 2010-09-20 |
 AEROCLEAR 79312773 not registered Live/Pending |
NIKKISO CO., LTD. 2021-04-05 |
 AEROCLEAR 79312530 not registered Live/Pending |
NIKKISO CO., LTD. 2021-04-05 |
 AEROCLEAR 76358333 2825824 Dead/Cancelled |
Akzo Nobel Coatings International B.V. 2002-01-14 |
 AEROCLEAR 73792085 1587664 Dead/Cancelled |
ANDERSON COMPANY OF INDIANA, THE 1989-04-10 |
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