Kit SST-A 10 for PC4200

GUDID B765PRD7150400

Kit SST-A for the retrofitting of the Helmer PC4200 incubator

BIOLOG-ID

Blood refrigerator/incubator

• Primary Device ID: B765PRD7150400
• NIH Device Record Key: bec7962e-02b7-4538-ab80-d265f7528712
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Kit SST-A 10 for PC4200
• Version Model Number: 01
• Company DUNS: 277828187
• Company Name: BIOLOG-ID
• 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: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B765PRD7150400 [Primary]

FDA Product Code

• KSE: Refrigerator, Freezer, Blood Storage

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: 2019-07-19
• Device Publish Date: 2019-07-11

Devices Manufactured by BIOLOG-ID

• B765PRD7150200 - Kit SST-A 30 for PF48: 2021-10-28 Kit SST-A for the retrofitting of the Helmer PF48
• B765PRD7170100 - Kit SST-R HD 45cm ColdRoom: 2021-10-28 Kit SST-R HD for the retrofitting shelves of cold room 45cm
• B765PRD7170200 - Kit SST-R HD 60cm ColdRoom: 2021-10-28 Kit SST-R HD for the retrofitting shelves of cold room 60cm
• B765PRD7170205 - Kit SST-R HD 60 cm: 2021-10-28 Kit SST-R HD for the retrofitting shelves of refrigerator 60cm
• B765PRD7130404 - Kit SST-R 4 shelves 3x2: 2020-02-21 Kit SST-R for the retrofitting of 4 shelves refrigerator 3 by 2 unit slots per shelves
• B765PRD7130100 - Kit SST-R 15 shelves 4x2: 2019-07-19 Kit SST-R for the retrofitting of 15 shelves refrigerator 4 by 2 unit slots per shelves
• B765PRD7130200 - Kit SST-R 15 shelves 4x3: 2019-07-19 Kit SST-R for the retrofitting of 15 shelves refrigerator 4 by 3 unit slots per shelves
• B765PRD7130300 - Kit SST-R 15 shelves 5x3: 2019-07-19 Kit SST-R for the retrofitting of 15 shelves refrigerator 5 by 3 unit slots per shelves