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 Surgical/emergency suction cannula, non-illuminating, single-use Surgical/emergency suction cannula, non-illuminating, single-use Surgical/emergency suction cannula, non-illuminating, single-use Surgical/emergency suction cannula, non-illuminating, single-use Surgical/emergency suction cannula, non-illuminating, single-use Surgical/emergency suction cannula, non-illuminating, single-use Surgical/emergency suction cannula, non-illuminating, single-use Surgical/emergency suction cannula, non-illuminating, single-use Surgical/emergency suction cannula, non-illuminating, single-use Surgical/emergency suction cannula, non-illuminating, single-use Surgical/emergency suction cannula, non-illuminating, single-use Surgical/emergency suction cannula, non-illuminating, single-use 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

• Phone: +1 651-855-1466
• Email: customerservice@hemostasisllc.com
• Phone: +1 651-855-1466
• Email: customerservice@hemostasisllc.com
• Phone: +1 651-855-1466
• Email: customerservice@hemostasisllc.com
• Phone: +1 651-855-1466
• Email: customerservice@hemostasisllc.com
• Phone: +1 651-855-1466
• Email: customerservice@hemostasisllc.com
• Phone: +1 651-855-1466
• Email: customerservice@hemostasisllc.com
• Phone: +1 651-855-1466
• Email: customerservice@hemostasisllc.com
• Phone: +1 651-855-1466
• Email: customerservice@hemostasisllc.com
• Phone: +1 651-855-1466
• Email: customerservice@hemostasisllc.com
• Phone: +1 651-855-1466
• Email: customerservice@hemostasisllc.com
• Phone: +1 651-855-1466
• Email: customerservice@hemostasisllc.com
• Phone: +1 651-855-1466
• Email: customerservice@hemostasisllc.com
• Phone: +1 651-855-1466
• Email: customerservice@hemostasisllc.com
• Phone: +1 651-855-1466
• Email: customerservice@hemostasisllc.com

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.

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

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• 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