Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007207474

FEI Number

3007207474

Entity Name

BARBARAS DEVELOPMENT, INC.

City/State/Country

Thousand Oaks, CA, US

Establishment Address

2545 W Hillcrest Dr Ste 215, Thousand Oaks, CA 91320, US

Establishment Type(s)

Manufacture Device in the United States for Export Only

Owner / Operator

Barbaras Development, Inc. (Owner Number: 10026520)

Owner / Operator Contact Address

2545 W HILLCREST DR STE 215, Thousand Oaks, CA 91320, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

EXERCISER 0184 CO2 Sampling line; 0184T CO2 Sampling line; 0139 CO2 Sampling line; 0182 CO2 Sampling line Procare DONJOY Post OP shoe Procare Stedline PICC Slee ECONO BREG/OPTIFLEX POM Cuffs CO2 Sampling Line for Non Breaking Oxygen Powered Moist Steam Pack Donjoy Procare Donjoy

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IOY	Support, Arm	Physical Medicine	Class 1	890.3475	2020-01-10
IOD	Components, Exercise	Physical Medicine	Class 1	890.5350	2026-03-03
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2025-06-17
ITW	Joint, Ankle, External Brace	Physical Medicine	Class 1	890.3475	2019-07-05
OEA	Non-Surgical Gown	General, Plastic Surgery	Class 1	878.4040	2024-12-12
IPG	Shoe, Cast	Physical Medicine	Class 1	890.3025	2019-01-13
FMP	Protector, Skin Pressure	General Hospital	Class 1	880.6450	2019-07-05
CAE	Airway, Oropharyngeal, Anesthesiology	Anesthesiology	Class 1	868.5110	2024-12-12
KMK	Device, Intravascular Catheter Securement	General Hospital	Class 1	880.5210	2019-01-13
ILZ	Accessories, Traction	Physical Medicine	Class 1	890.5925	2019-01-13
BYG	Mask, Oxygen	Anesthesiology	Class 1	868.5580	2016-11-25
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2023-03-01
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2020-01-10
CAT	Cannula, Nasal, Oxygen	Anesthesiology	Class 1	868.5340	2026-03-03
IMA	Pack, Heat, Moist	Physical Medicine	Class 1	890.5730	2019-01-13
BTQ	Airway, Nasopharyngeal	Anesthesiology	Class 1	868.5100	2024-12-12
KYS	Insoles, Medical	General Hospital	Class 1	880.6280	2023-09-26
ITQ	Joint, Knee, External Brace	Physical Medicine	Class 1	890.3475	2019-01-13
KYS	Insoles, Medical	General Hospital	Class 1	880.6280	2023-10-31

Official Correspondent

Amy XU

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Barbaras Development, 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
K142467	Abeon Medical Corporation	IntelAir Nasal Airway Support System	2014-11-24
K861213	Datex Division Instrumentarium Corp.	PB 254 IR - SPECTROMETER	1986-04-04
K172904	Philips Medizin Systeme Boeblingen GmbH	IntelliVue Capnography Extension, IntelliVue Microstream Extension	2017-12-26

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0021-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20P (US) N, Part Number CS08651-01
Z-0024-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20 (US) N W/PRINTER, Part Number CS08657
Z-0025-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20P (US) N W/PRINTER - ROHS, Part Number CS08657-02
Z-0026-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20P (US) N W/PRINTER, Part Number CS08657-01
Z-0027-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20P (US) N W/PRINTER - ROHS, Part Number CS08657-03

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007207474. Last updated year: 2026. Please use registration number 3007207474 when referencing this establishment in official correspondence.