Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1819470

FEI Number

1819470

Entity Name

Eli Lilly and Company, Pharmaceutical Delivery Systems

City/State/Country

Indianapolis, IN, US

Establishment Address

Lilly Corporate Center, Indianapolis, IN 46285, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device

Owner / Operator

ELI LILLY AND CO. (Owner Number: 1819470)

Owner / Operator Contact Address

LILLY CORPORATE CENTER, Drop Code 1084, Indianapolis, IN 46285, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

HumaPen Savvio Tempo Smart Button HumaPen Ergo II HumatroPen 6mg HumatroPen 12mg HumatroPen 24mg

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2016-06-07
OCN	Insulin Autoantibody Kit	Immunology	Class 2	866.5660	2022-10-14
QOG	Injection Data Capture Device	General Hospital	Class 2	880.5860	2022-10-14
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2016-01-13
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2016-07-27

Official Correspondent

Karthik Iyer

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

ELI LILLY AND CO.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K880350	Honway International Co.	YUE/FA DISPOSABLE SYRINGE	1988-02-16
K003571	Terumo Medical Corp.	SERONO FOR USE WITH GONAL-F 1200IU MULTI-DOSE ONLY AT 600IU/ML SYRINGE	2001-02-12

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0003-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 30G X 5/16'' syringes
Z-0004-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1 cc X 29G X 1/2 '' insulin syringes
Z-0005-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 29G X 1/2 '' insulin syringes
Z-0005-2024	Fresenius Medical Care Holdings, Inc.	2	10ML SYRINGE LUER LOCK W/OUT NEEDLE, Part Number 15-R010-0, 100 per box, 12 boxes to a case
Z-0006-2024	Fresenius Medical Care Holdings, Inc.	2	10ML SYRINGE LUER LOCK W/NEEDLE, Part Number 15-10ML-0, 100 per box, 12 boxes per case

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1819470. Last updated year: 2026. Please use registration number 1819470 when referencing this establishment in official correspondence.