SAM Chest Seal

GUDID 10822045000183

SAM Chest Seal Valved 2.0

SAM Medical Products

Pneumothorax dressing Pneumothorax dressing Pneumothorax dressing Pneumothorax dressing Pneumothorax dressing Pneumothorax dressing Pneumothorax dressing Pneumothorax dressing Pneumothorax dressing Pneumothorax dressing Pneumothorax dressing Pneumothorax dressing Pneumothorax dressing Pneumothorax dressing Pneumothorax dressing Pneumothorax dressing

• Primary Device ID: 10822045000183
• NIH Device Record Key: 7c688620-89be-4387-b60d-1ff4f4da252d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SAM Chest Seal
• Version Model Number: CS202-EN
• Company DUNS: 131084188
• Company Name: SAM Medical Products
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 5036395474
• Email: raqa@sammedical.com
• Phone: 5036395474
• Email: raqa@sammedical.com
• Phone: 5036395474
• Email: raqa@sammedical.com
• Phone: 5036395474
• Email: raqa@sammedical.com
• Phone: 5036395474
• Email: raqa@sammedical.com
• Phone: 5036395474
• Email: raqa@sammedical.com
• Phone: 5036395474
• Email: raqa@sammedical.com
• Phone: 5036395474
• Email: raqa@sammedical.com
• Phone: 5036395474
• Email: raqa@sammedical.com
• Phone: 5036395474
• Email: raqa@sammedical.com
• Phone: 5036395474
• Email: raqa@sammedical.com
• Phone: 5036395474
• Email: raqa@sammedical.com
• Phone: 5036395474
• Email: raqa@sammedical.com
• Phone: 5036395474
• Email: raqa@sammedical.com
• Phone: 5036395474
• Email: raqa@sammedical.com
• Phone: 5036395474
• Email: raqa@sammedical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00822045000186 [Primary]
GS1	10822045000183 [Package]; Contains: 00822045000186; Package: Case [25 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K102403

FDA Product Code

• NAD: Dressing, Wound, Occlusive

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: 2022-09-09
• Device Publish Date: 2022-09-01

On-Brand Devices [SAM Chest Seal]

• 10822045000190: SAM Chest Seal Combo
• 10822045000183: SAM Chest Seal Valved 2.0
• 20822045000173: SAM Chest Seal Non-Valved