SAM Chest Seal

GUDID 10822045000183

SAM Chest Seal Valved 2.0

SAM Medical Products

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