FDA.reportPublic FDA data

FOGG SYSTEM COMPANY, INC.

Primary DI
00840416606935
Brand
FOGG SYSTEM COMPANY, INC.
Company
Fogg System Company, Inc.
Model
0310-2326
Device description
0310-2326 Interface Cable
Published
2026-06-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
Single use
false

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
00840416606935PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840416606935008404166069358404166069350840416606935

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.

Contacts#

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

Regulatory Flags#

DUNS number
058730946
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840416607079FOGG SYSTEM COMPANY, INC.0403-24502026-08-03
00840416607086FOGG SYSTEM COMPANY, INC.0362-2585:L242026-08-03
00840416607093FOGG SYSTEM COMPANY, INC.0259-25082026-08-03
00840416607109FOGG SYSTEM COMPANY, INC.0431-24172026-08-03
00840416607116FOGG SYSTEM COMPANY, INC.0407-23962026-08-03
00840416607123FOGG SYSTEM COMPANY, INC.0386-25502026-08-03
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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840416607079FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-08-03
00840416607086FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-08-03
00840416607093FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-08-03
00840416607109FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-08-03
00840416607116FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-08-03
00840416607123FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-08-03
00840309445672Viva ComfortTiger Supplies IncDSA2026-08-01
00840309445689Viva ComfortTiger Supplies IncDSA2026-08-01
G662ME3641MaguireMaguire Enterprises, Inc.DSA2026-07-31
G662ME5900951MaguireMaguire Enterprises, Inc.DSA2026-07-29
G662ME590333B1MaguireMaguire Enterprises, Inc.DSA2026-07-29
G662ME590280L1MaguireMaguire Enterprises, Inc.DSA2026-07-28
G662ME590280M1MaguireMaguire Enterprises, Inc.DSA2026-07-28
G662ME590280T11MaguireMaguire Enterprises, Inc.DSA2026-07-28
G662ME590280Y1MaguireMaguire Enterprises, Inc.DSA2026-07-28
03700506300853INTEGRAL PROCESS Cables & LeadwiresNISSHA MEDICAL TECHNOLOGIES SASDSA2026-07-24
G662ME5900321MaguireMaguire Enterprises, Inc.DSA2026-07-23
04048675379300IBP Cable UtahDrägerwerk AG & Co. KGaADSA2026-01-07
04048675557722IBP Adapter Cable Dräger 7pinDrägerwerk AG & Co. KGaADSA2026-01-07
04048675379072IBP cable Becton DickinsonDrägerwerk AG & Co. KGaADSA2026-01-06
04048675379089IBP Cable Abbott, MedexDrägerwerk AG & Co. KGaADSA2026-01-06
04048675379096IBP cable EdwardsDrägerwerk AG & Co. KGaADSA2026-01-06
04048675557739IBP Adapter Cable Drager 10pinDrägerwerk AG & Co. KGaADSA2026-01-06
00816396022553ECG Patient CableIVY BIOMEDICAL SYSTEMS, INC.DSA2023-06-08
00816396022560ECG Patient CableIVY BIOMEDICAL SYSTEMS, INC.DSA2023-06-08
00816396022577ECG Patient CableIVY BIOMEDICAL SYSTEMS, INC.DSA2023-06-08
00816396022706ECG Patient CableIVY BIOMEDICAL SYSTEMS, INC.DSA2023-06-08
00816396022713ECG Patient CableIVY BIOMEDICAL SYSTEMS, INC.DSA2023-06-08
00816396022812ECG Trunk CableIVY BIOMEDICAL SYSTEMS, INC.DSA2023-06-08
00816396022829ECG Patient CableIVY BIOMEDICAL SYSTEMS, INC.DSA2023-06-08