Cardiovascular Procedure Kit

GUDID 50699753515487

Terumo Cardiovascular Systems Corporation

Cardioplegia solution administration kit

• Primary Device ID: 50699753515487
• NIH Device Record Key: 5ca0dcda-eea8-44ee-82ba-b6c0a77c398b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cardiovascular Procedure Kit
• Version Model Number: 77628
• Company DUNS: 177655466
• Company Name: Terumo Cardiovascular Systems Corporation
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00699753515482 [Primary]
GS1	50699753515487 [Package]; Contains: 00699753515482; Package: 5 PIECE CASE [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K823451

FDA Product Code

• DTR: Heat-Exchanger, Cardiopulmonary Bypass

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: 2021-11-05
• Device Publish Date: 2021-10-28

On-Brand Devices [Cardiovascular Procedure Kit]

• 50699753509790: 66774
• 50699753509769: 76969
• 50699753509752: 76970
• 50699753509738: 66743
• 00699753509726: 74109-01
• 50699753509714: 76967
• 50699753509707: 76954
• 00699753509696: 76881
• 00699753509689: 76949
• 00699753509672: 76854
• 50699753509660: 76951
• 00699753509658: 74324-02
• 50699753509646: 76928
• 50699753509639: 70778-01
• 50699753509622: 70779-01
• 50699753509615: 70781-01
• 50699753509608: 73109-01
• 00699753509597: 70571-07
• 00699753509580: 76921
• 50699753509578: 76962
• 00699753509566: B76872-01
• 00699753509542: 75876-02
• 00699753509535: 76878
• 50699753509523: 76869
• 50699753509516: 76903
• 00699753509504: 76922
• 50699753509493: 76939
• 50699753509486: 66762
• 00699753509474: 76873-01
• 00699753509467: 73782-01
• 50699753509455: 76940
• 00699753509443: 76848
• 00699753509436: 76847
• 50699753509424: 76842
• 00699753509412: B75876-02
• 00699753509405: 76944
• 00699753509399: 72226-04
• 00699753509382: 72225-03
• 50699753509370: 66653
• 50699753509363: 66652
• 50699753509356: 66651
• 50699753509349: 66650
• 00699753509337: 66649
• 00699753509320: 66648
• 00699753509313: 66647
• 00699753509306: 76838
• 50699753509295: 76820
• 50699753509288: 76906
• 50699753509271: 76904
• 50699753509264: 76901