See Instructions for OMB Statement. DEPARTMENT OF HEALTH AND HUMAN SERVICES PUBLIC HEALTH SERVICE FOOD AND DRUG ADMINISTRATION (FDA Establishment Identifier) ESTABLISHMENT REGISTRATION AND LISTING FOR HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS (HCT/Ps) FEI: c. DRUG FDA 2656 NO. Types of HCT / Ps 4. PHYSICAL LOCATION (Include legal name, number and street, city, state, country, and post office code) New York Blood Center, Inc. Recover Screen Test Package Process Store Label Distribute X X X X X X X 13. HCT/Ps REGULATED AS DRUGS OR BIOLOGICAL DRUGS NO. 10. ESTABLISHMENT FUNCTIONS AND TYPES OF HCT / Ps Establishment Functions FEI: 0002476837 12. HCT/Ps REGULATED AS MEDICAL DEVICES b. DEVICES FDA 2891 INACTIVE 11. HCT/Ps DESCRIBED IN 21 CFR 1271.10 NO. d. X PART II - PRODUCT INFORMATION 3. OTHER FDA REGISTRATIONS a. BLOOD FDA 2830 c. VALIDATION--FOR FDA USE ONLY VALIDATED BY FDA:26-NOV-2014 ANNUAL REGISTRATION / LISTING DISTRICT: New York PRINTED BY FDA:04-DEC-2014 CHANGE IN INFORMATION b. 0002476837 (See reverse side for instructions) PART I - ESTABLISHMENT INFORMATION FORM APPROVED:OMB No.0910-0543. Expiration Date: 3/31/2017 2. REASON FOR SUBMISSION a. INITIAL REGISTRATION / LISTING 1. REGISTRATION NUMBER a. Bone b. Cartilage 310 E 67th St. New York, New York 10065 c. Cornea d. Dura Mater SIP Directed Anonymous e. Embryo EXT a. PHONE 212-570-3488 b. SATELLITE RECOVERY ESTABLISHMENT (MANUFACTURING ESTABLISHMENT FEI NO._________________ c. TESTING FOR MICRO-ORGANISMS ONLY f. Fascia g. Heart Valve 5. ENTER CORRECTIONS TO ITEM 4 h. Ligament 6. MAILING ADDRESS OF REPORTING OFFICIAL (Include institution name if applicable, number and street, city, state, country, and post office code) New York Blood Center, Inc. Attn: Christine Driscoll 1200 Prospect Avenue Westbury, New York 11590 SIP Directed Anonymous i. Oocyte j. Pericardium k. Peripheral Blood Stem X X X Autologous Family Related Allogeneic X X l. Sclera a. PHONE 516-478-5264 7. ENTER CORRECTIONS TO ITEM 6 SIP Directed Anonymous m. Semen EXT b. PHONE n. Skin o. Somatic Cell Therapy Products 8. U.S. AGENT X X X X X Autologous Family Related Allogeneic X X X X X X X X X X X X X X X X X X X X X X X r. Vascular Graft a. E-MAIL 9. REPORTING OFFICIAL'S SIGNATURE s. Parathyroid t. Therapeutic Cells a. TYPED NAME FORM FDA - 3356 (5/14) X p. Tendon q. Umbilical Cord Blood Christine Driscoll b. E-MAIL [email protected] c. TITLE Director, Regulatory Affairs Autologous Family Related Allogeneic u. d. DATE 25-NOV-2014 v. X 14. PROPRIETARY NAME(S) 1
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