FDA.reportPublic FDA data

Viva Comfort

Primary DI
00840309445672
Brand
Viva Comfort
Company
Tiger Supplies Inc
Model
ADIME913-BPEC-10
Published
2026-08-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

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
K231961000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K231961000NIBPCuffShenzhen Sino-K Medical Technology Co.,Ltd2023-08-30DXQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840309445672PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840309445672008403094456728403094456720840309445672

GMDN Terms#

Term, Definition table
TermDefinition
Blood pressure/neuromuscular transmission monitoring cuff extension tubing/cableA length of pneumatic tubing with an integrated electrical cable intended to be connected to the existing tubing/cable of a blood pressure/neuromuscular transmission monitoring cuff (not included) to increase its length, during combined intraoperative noninvasive blood pressure (NIBP) and neuromuscular transmission (NMT) monitoring. This is a reusable device.

Regulatory Flags#

DUNS number
013719334
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
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
00840309445689Viva ComfortADIME913-SPEC-122026-08-01
00840309445696Viva ComfortADIME913-BPCP2026-08-01
00840309415880Viva DiagnosticADIME913-T2024-06-01
00840309415903Viva DiagnosticADIME913-M2024-06-01
00840309416054Viva DiagnosticADIME913-S2024-06-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03700506301775INTEGRAL PROCESS Cables & LeadwiresNISSHA MEDICAL TECHNOLOGIES SASDSA2026-08-27
G662ME590032R1MaguireMaguire Enterprises, Inc.DSA2026-08-25
00840416607130FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-08-17
00840416607147FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-08-17
00840416607154FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-08-17
00840416607161FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-08-17
00840416607178FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-08-17
00840416607185FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-08-17
08720938410383Cardiac, 10-Lead, IEC, Basic Monitoring KitFysicon B.V.DSA2026-08-14
08720938410390Cardiac, 10-Lead, AHA, Basic Monitoring KitFysicon B.V.DSA2026-08-14
08720938410406IR, 5-Lead, IEC, Basic Monitoring KitFysicon B.V.DSA2026-08-14
08720938410413IR, 5-Lead, AHA, Basic Monitoring KitFysicon B.V.DSA2026-08-14
08720938410420ACIST FFR Connection KitFysicon B.V.DSA2026-08-14
08720938410437Volcano (Philips) FFR Connection KitFysicon B.V.DSA2026-08-14
08720938410444ABBOTT FFR Connection KitFysicon B.V.DSA2026-08-14
08720938410451BOSTON FFR Connection KitFysicon B.V.DSA2026-08-14
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
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