Axiom® CWV Atraum™ With ClotStop®

GUDID M6653643ATSP1

Closed Wound Drain, Round, Silicone, With ClotStop®

AXIOM MEDICAL, INCORPORATED

Closed-wound drain, non-bioabsorbable Closed-wound drain, non-bioabsorbable Closed-wound drain, non-bioabsorbable Closed-wound drain, non-bioabsorbable Closed-wound drain, non-bioabsorbable Closed-wound drain, non-bioabsorbable Closed-wound drain, non-bioabsorbable Closed-wound drain, non-bioabsorbable Closed-wound drain, non-bioabsorbable Closed-wound drain, non-bioabsorbable Closed-wound drain, non-bioabsorbable Closed-wound drain, non-bioabsorbable Closed-wound drain, non-bioabsorbable Closed-wound drain, non-bioabsorbable Closed-wound drain, non-bioabsorbable Closed-wound drain, non-bioabsorbable

• Primary Device ID: M6653643ATSP1
• NIH Device Record Key: 1886e33c-ff54-446d-be2d-5cc75ced126c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Axiom® CWV Atraum™ With ClotStop®
• Version Model Number: 3643ATSP
• Company DUNS: 094439676
• Company Name: AXIOM MEDICAL, INCORPORATED
• 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: 310-533-9020
• Email: Sales@AxiomMed.com
• Phone: 310-533-9020
• Email: Sales@AxiomMed.com
• Phone: 310-533-9020
• Email: Sales@AxiomMed.com
• Phone: 310-533-9020
• Email: Sales@AxiomMed.com
• Phone: 310-533-9020
• Email: Sales@AxiomMed.com
• Phone: 310-533-9020
• Email: Sales@AxiomMed.com
• Phone: 310-533-9020
• Email: Sales@AxiomMed.com
• Phone: 310-533-9020
• Email: Sales@AxiomMed.com
• Phone: 310-533-9020
• Email: Sales@AxiomMed.com
• Phone: 310-533-9020
• Email: Sales@AxiomMed.com
• Phone: 310-533-9020
• Email: Sales@AxiomMed.com
• Phone: 310-533-9020
• Email: Sales@AxiomMed.com
• Phone: 310-533-9020
• Email: Sales@AxiomMed.com
• Phone: 310-533-9020
• Email: Sales@AxiomMed.com
• Phone: 310-533-9020
• Email: Sales@AxiomMed.com
• Phone: 310-533-9020
• Email: Sales@AxiomMed.com

Device Dimensions

• Device Size Text, specify: 0
• Length: 36 Inch
• Device Size Text, specify: 0
• Length: 36 Inch
• Device Size Text, specify: 0
• Length: 36 Inch
• Device Size Text, specify: 0
• Length: 36 Inch
• Device Size Text, specify: 0
• Length: 36 Inch
• Device Size Text, specify: 0
• Length: 36 Inch
• Device Size Text, specify: 0
• Length: 36 Inch
• Device Size Text, specify: 0
• Length: 36 Inch
• Device Size Text, specify: 0
• Length: 36 Inch
• Device Size Text, specify: 0
• Length: 36 Inch
• Device Size Text, specify: 0
• Length: 36 Inch
• Device Size Text, specify: 0
• Length: 36 Inch
• Device Size Text, specify: 0
• Length: 36 Inch
• Device Size Text, specify: 0
• Length: 36 Inch
• Device Size Text, specify: 0
• Length: 36 Inch
• Device Size Text, specify: 0
• Length: 36 Inch

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M6653643ATSP0 [Primary]
HIBCC	M6653643ATSP1 [Package]; Contains: M6653643ATSP0; Package: Box [10 Units]; In Commercial Distribution
HIBCC	M6653643ATSP3 [Package]; Package: Case [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K883887

FDA Product Code

• GBS: Catheter, Ventricular, General & Plastic Surgery

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2022-03-08
• Device Publish Date: 2020-11-13

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• M665803621AT3: Closed Wound Drain, Flat, Silicone, With Trocar, With ClotStop®
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• M6653643ATSP1: Closed Wound Drain, Round, Silicone, With ClotStop®
• M6653643AT3: Closed Wound Drain, Round, Silicone, With ClotStop®
• M6653642AT3: Closed Wound Drain, Round, Silicone, With ClotStop®
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• M6653640ATSP1: Closed Wound Drain, Round, Silicone, With ClotStop®
• M6653640AT3: Closed Wound Drain, Round, Silicone, With ClotStop®
• M6653631AT3: Closed Wound Drain, Flat, Silicone, With ClotStop®
• M6653626AT3: Closed Wound Drain, Flat, Silicone, With ClotStop®
• M6653621AT3: Closed Wound Drain, Flat, Silicone, With ClotStop®
• M6653603AT3: Closed Wound Drain, Flat, Silicone, With Reservoir, With ClotStop®
• M6653602AT3: Closed Wound Drain, Flat, Silicone, With Reservoir, With ClotStop®
• M6653601AT3: Closed Wound Drain, Flat, Silicone, With Reservoir, With ClotStop®