FDA.reportPublic FDA data

FOGG SYSTEM COMPANY, INC.

Primary DI
00840416605112
Brand
FOGG SYSTEM COMPANY, INC.
Company
Fogg System Company, Inc.
Model
0386-2291
Device description
0386-2291 Interface Cable
Published
2025-04-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DSACABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DSACable, Transducer And Electrode, Patient, (Including Connector)Cardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K222712000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K222712000Fogg System Patient Monitoring CablesFogg System Company, Inc.2023-11-22DSA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840416605112PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840416605112008404166051128404166051120840416605112

GMDN Terms#

Term, Definition table
TermDefinition
Electrical-only medical device connection cable, reusableA non-patient-contact, insulated, electrical cord with a connector (plug) at both ends designed to transmit electrical power and/or signal (data) between medical devices (e.g., to connect a lead, electrical catheter, handpiece, or monitor to a parent device). It is not intended to connect directly to patient-worn electrodes (i.e., it is not a lead), is not intended to connect to the mains (i.e., not a mains power cable), does not generate any type of power and/or signal, and has no additional non-electrical conducting or processing functionality. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(303)344-1883compliance@foggsystem.com

Regulatory Flags#

DUNS number
058730946
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840416606898FOGG SYSTEM COMPANY, INC.0464-22522026-06-02
00840416606904FOGG SYSTEM COMPANY, INC.0310-2571:L782026-06-02
00840416606911FOGG SYSTEM COMPANY, INC.0464-23532026-06-02
00840416606928FOGG SYSTEM COMPANY, INC.0395-25992026-06-02
00840416606935FOGG SYSTEM COMPANY, INC.0310-23262026-06-02
00840416606942FOGG SYSTEM COMPANY, INC.0464-25182026-06-02
00840416606959FOGG SYSTEM COMPANY, INC.0259-16552026-06-02
00840416606881FOGG SYSTEM COMPANY, INC.0432-2417:L802026-05-14
00840416606812FOGG SYSTEM COMPANY, INC.0178-22732026-04-30
00840416606829FOGG SYSTEM COMPANY, INC.0310-25412026-04-30
00840416606836FOGG SYSTEM COMPANY, INC.0395-24032026-04-30
00840416606843FOGG SYSTEM COMPANY, INC.0395-22262026-04-30
00840416606850FOGG SYSTEM COMPANY, INC.0395-25182026-04-30
00840416606867FOGG SYSTEM COMPANY, INC.7382-00132026-04-30
00840416606874FOGG SYSTEM COMPANY, INC.0362-25942026-04-30
00840416606751FOGG SYSTEM COMPANY, INC.0346-19412026-04-15
00840416606768FOGG SYSTEM COMPANY, INC.0395-20542026-04-15
00840416606775FOGG SYSTEM COMPANY, INC.0395-24272026-04-15
00840416606782FOGG SYSTEM COMPANY, INC.7382-00112026-04-15
00840416606799FOGG SYSTEM COMPANY, INC.0360-19692026-04-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G662ME590030R1MaguireMaguire Enterprises, Inc.DSA2026-07-14
04048675729631ECG trunk cable 12-lead SinglePin Vista300Shanghai Draeger Medical Instrument Co.,Ltd.DSA2026-07-13
04048675729655Adapter cable Masimo/ Nellcor SpO2 Vista 300Shanghai Draeger Medical Instrument Co.,Ltd.DSA2026-07-13
04048675746768Temp adapter Jack Vista 300Shanghai Draeger Medical Instrument Co.,Ltd.DSA2026-07-13
06931973403939CaremedShenzhen Caremed Medical Technology Co., Ltd.DSA2026-07-09
06931973435398CaremedShenzhen Caremed Medical Technology Co., Ltd.DSA2026-07-09
06931973435404CaremedShenzhen Caremed Medical Technology Co., Ltd.DSA2026-07-09
06931973435411CaremedShenzhen Caremed Medical Technology Co., Ltd.DSA2026-07-09
06931973439082CaremedShenzhen Caremed Medical Technology Co., Ltd.DSA2026-07-09
06931973457116CaremedShenzhen Caremed Medical Technology Co., Ltd.DSA2026-07-09
06931973457123CaremedShenzhen Caremed Medical Technology Co., Ltd.DSA2026-07-09
06931973457130CaremedShenzhen Caremed Medical Technology Co., Ltd.DSA2026-07-09
06931973457147CaremedShenzhen Caremed Medical Technology Co., Ltd.DSA2026-07-09
06931973457154CaremedShenzhen Caremed Medical Technology Co., Ltd.DSA2026-07-09
06931973457161CaremedShenzhen Caremed Medical Technology Co., Ltd.DSA2026-07-09
06931973457185CaremedShenzhen Caremed Medical Technology Co., Ltd.DSA2026-07-09
06931973457192CaremedShenzhen Caremed Medical Technology Co., Ltd.DSA2026-07-09
06931973457208CaremedShenzhen Caremed Medical Technology Co., Ltd.DSA2026-07-09
06931973457215CaremedShenzhen Caremed Medical Technology Co., Ltd.DSA2026-07-09
06931973457246CaremedShenzhen Caremed Medical Technology Co., Ltd.DSA2026-07-09
08720938410284QMAPPFysicon B.V.DSA2026-06-26
G662ME590030M31MaguireMaguire Enterprises, Inc.DSA2026-06-24
G662ME5921011MaguireMaguire Enterprises, Inc.DSA2026-06-10
00840416606898FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-06-02
00840416606904FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-06-02
00840416606911FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-06-02
00840416606928FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-06-02
00840416606935FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-06-02
00840416606942FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-06-02
00840416606959FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-06-02