Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1219205

FEI Number

1219205

Entity Name

Boehringer Ingelheim Pharmaceuticals, Inc.

City/State/Country

Ridgefield, CT, US

Establishment Address

900 Ridgebury Rd, Ridgefield, CT 06877, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Boehringer Ingelheim Pharmaceuticals, Inc. (Owner Number: 10043269)

Owner / Operator Contact Address

900 Ridgebury Road, PO Box 368, Ridgefield, CT 06877, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Cyltezo Pen

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KZH	Introducer, Syringe Needle	General Hospital	Class 2	880.6920	2026-01-30
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2026-01-30
QKS	Inhaler, Metered Dose Or Dry Powder, Cder Or Cber Led	Unknown	Class N	N/A	2026-01-30

Official Correspondent

Andrew Gee

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Boehringer Ingelheim Pharmaceuticals, Inc.

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 1219205. Last updated year: 2026. Please use registration number 1219205 when referencing this establishment in official correspondence.