| Primary Device ID | 50699753535935 | 
| NIH Device Record Key | e2497073-296f-441b-98e9-68d2eda9381c | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | Cardiovascular Procedure Kit | 
| Version Model Number | 78412 | 
| Company DUNS | 177655466 | 
| Company Name | Terumo Cardiovascular Systems Corporation | 
| Device Count | 1 | 
| DM Exempt | false | 
| Pre-market Exempt | true | 
| MRI Safety Status | Labeling does not contain MRI Safety Information | 
| Human Cell/Tissue Product | false | 
| Device Kit | true | 
| 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 | true | 
| Labeled No Natural Rubber Latex | false | 
| RX Perscription | true | 
| OTC Over-The-Counter | false | 
| Device Issuing Agency | Device ID | 
|---|---|
| GS1 | 00699753535930 [Primary] | 
| GS1 | 50699753535935 [Package] Contains: 00699753535930 Package: 2 PIECE CASE [2 Units] In Commercial Distribution | 
| Steralize Prior To Use | false | 
| Device Is Sterile | true | 
| Public Version Status | New | 
| Device Record Status | Published | 
| Public Version Number | 1 | 
| Public Version Date | 2025-08-19 | 
| Device Publish Date | 2025-08-11 | 
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