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DEPARTMENT OF HEALTH AND HUMAN SERVICES
FOOD AND DRUG ADMINISTRATION

INFUSION PUMP INFORMATION SUBMISSION REPORT
MANUFACTURER NAME PUMP BRAND NAME PUMP MODEL NUMBER

See Burden Statement on back of form. Form Approved: OMB No. 0910-0387, Expiration Date: April 30, 2008.
FDA SUBMISSION NO. (for FDA) YEAR MARKETED (for FDA) PREVIOUS MANUFACTURER(S)

1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13. 14. 15. 16. 17. 18. 19. 20.

FORM FDA 3571 (6/06) (FRONT)

PSC Graphics: (301) 443-1090 EF

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INFUSION PUMP INFORMATION SUBMISSION REPORT (continued)
CONTACT PERSON (for FDA) CONTACT PHONE NO. (for FDA) CONTACT PHONE NO. (for Consumers) MAILING ADDRESS CITY STATE ZIP CODE WEBSITE ADDRESS

1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13. 14. 15. 16. 17. 18. 19. 20. Public reporting burden Public reporting burden for this collection of information is estimated to average 1-2 hours per submission form, including the time for reviewing instructions, searching existing data sources, adhering and maintaining the data needed, and completing and reviewing the collection of information. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Center for Devices and Radiological Health 1350 Piccard Drive, 340N Rockville, MD 20850

FORM FDA 3571 (6/06) (BACK)