Drop-It™ Quick Release Needle Holders 4550

GUDID 16641670019230

Cardiomed Supplies Inc

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• Primary Device ID: 16641670019230
• NIH Device Record Key: 5d25c93c-c831-4c7b-99c6-cae6d62ecdf1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Drop-It™ Quick Release Needle Holders
• Version Model Number: 1.1
• Catalog Number: 4550
• Company DUNS: 240623124
• Company Name: Cardiomed Supplies Inc
• Device Count: 50
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	16641670019230 [Unit of Use]
GS1	36641670019241 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K963748

FDA Product Code

• FMI: Needle, Hypodermic, Single Lumen

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-04-29
• Device Publish Date: 2021-04-21

Devices Manufactured by Cardiomed Supplies Inc

• 16641670001303 - Adult Heart Cooling Jacket: 2021-04-29 The Heart Cooling Jacket is effective in controlling the temperature of the cardiac organ during an open heart surgery. The clos
• 16641670001327 - Adult Heart Cooling Jacket Recirculation Set: 2021-04-29
• 16641670001341 - Pediatric Heart Cooling Jacket: 2021-04-29
• 16641670011517 - rescuCLAMP™ Catheter Repair Clamp: 2021-04-29 The Catheter Repair Clamp is designed with additional openings along the side and the top of the clamp to be quickly added or re
• 16641670019230 - Drop-It™ Quick Release Needle Holders: 2021-04-29
• 16641670019230 - Drop-It™ Quick Release Needle Holders: 2021-04-29
• 16641670004168 - 3/8'' x 1/4'' x 3/8'' Y Connector: 2020-12-10 This device is intended for use during cardiopulmonary bypass in conjunction with other medically approved devices and equipment
• 16641670004182 - 1/2'' x 3/8'' x 3/8'' Y Connector: 2020-12-10 This device is intended for use during cardiopulmonary bypass in conjunction with other medically approved devices and equipment
• 16641670004205 - 3/8'' x 1/4'' x 1/4'' Y Connector: 2020-12-10 This device is intended for use during cardiopulmonary bypass in conjunction with other medically approved devices and equipment