THE JAY GROUP

FDA Device Registration & Listing · Lancaster, PA, US · Registration 3006479639

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3006479639
FEI Number
3006479639
Entity Name
THE JAY GROUP
City/State/Country
Lancaster, PA, US
Establishment Address
700 Indian Springs Drive, Lancaster, PA 17601, US
Establishment Type(s)
Repack or Relabel Medical Device
Owner / Operator
The Jay Group (Owner Number: 10021837)
Owner / Operator Contact Address
700 Indian Springs Drive, Lancaster, PA 17601, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K230419
PMA Number
N/A

All Registered Proprietary Names

BD TPC Inc. DBA August BD Lelo Usa Inc. Animas Lelo Usa Inc. Lelo Usa Inc. Healthyio Lelo Hex Lubricated Natural Rubber Latex Condom; Lelo Hex Lubricated Natural Rubber Latex Condom 12’s; Lelo Hex Lubricat Animas MOSIE LLC Fillow Lily Cup One; Ziggy Cup BD TPC Inc. DBA August Sequel

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2007-10-02
HHD Pad, Menstrual, Unscented Obstetrics/Gynecology Class 1 884.5435 2025-06-19
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2007-10-02
HIR Perineometer Obstetrics/Gynecology Class 2 884.1425 2026-06-08
LZG Pump, Infusion, Insulin General Hospital Class 2 880.5725 2007-10-02
LKY Device, External Penile Rigidity Gastroenterology, Urology Class 2 876.5020 2026-06-08
ISA Massager, Therapeutic, Electric Physical Medicine Class 1 890.5660 2026-06-08
KQO Automated Urinalysis System Clinical Chemistry Class 1 862.2900 2026-04-23
JIR Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) Clinical Chemistry Class 1 862.1645 2026-04-23
JFY Enzymatic Method, Creatinine Clinical Chemistry Class 2 862.1225 2026-04-23
HIS Condom Obstetrics/Gynecology Class 2 884.5300 2026-06-08
LZG Pump, Infusion, Insulin General Hospital Class 2 880.5725 2007-10-02
LCX Kit, Test, Pregnancy, Hcg, Over The Counter Clinical Chemistry Class 2 862.1155 2022-08-11
DHA System, Test, Human Chorionic Gonadotropin Clinical Chemistry Class 2 862.1155 2022-08-11
HHE Cup, Menstrual Obstetrics/Gynecology Class 2 884.5400 2023-10-30
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2007-10-02
HEB Tampon, Menstrual, Unscented Obstetrics/Gynecology Class 2 884.5470 2025-06-19

Official Correspondent

Gene Palow

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

The Jay Group
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3017125176 Jay Group Reno, NV, US

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K221518 Np Medical NP Medical nCompass Extension Set with Stabilizing Base 2022-11-03
K953474 Medikmark, Inc. IV START KIT 1995-10-02
K972493 Nipro Medical Corp. NIPRO DISPOSABLE SOLUTION INFUSION SET 1997-09-18
K982672 Baxter Healthcare Corp COLLEAGUE PUMP SYRINGE ADAPTER SET 1998-09-04
K143446 Roche Diagnostics GmbH Accu-Chek FlexLink Plus infusion set 2015-08-13

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0010-2025 Smiths Medical ASD Inc. 2
CADD Medication Cassette Reservoir, 100mL, Product Code 21-7002-24
Z-0011-2025 Smiths Medical ASD Inc. 2
CADD Medication Cassette Reservoir, 100mL, FS, Product Code 21-7302-24
Z-0012-2013 Baxter Healthcare Corp. Rt. 2
Baxter Interlink System Buretrol Solution Set with 150 mL Burette (Ball-Valve Drip Chamber); a sterile Rx IV fluid pathway device. Product Usage: The device is used for the administration of fluids from a container into the patient's vascular system through a vascular access device.
Z-0012-2025 Smiths Medical ASD Inc. 2
CADD Medication Cassette Reservoir, 100mL, FS, YELLOW, Product Code 21-7300-24
Z-0013-2013 Baxter Healthcare Corp. Rt. 2
Baxter Interlink System Buretrol Solution Set, 117" (3.0 m), with 150 mL Burette (Ball-Valve Drip Chamber) (Non-DEHP); a sterile Rx IV fluid pathway device; Product Usage: The device is used for the administration of fluids from a container into the patient's vascular system through a vascular access device.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006479639. Last updated year: 2026. Please use registration number 3006479639 when referencing this establishment in official correspondence.
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