FDA.reportPublic FDA data

MedCuff

Primary DI
96973521872067
Brand
MedCuff
Company
Shenzhen Vistar Medical Supplies Co.,Ltd.
Model
V1010P
Device description
Disposable Pressure Infusion Bag,mesh back,1000ml
Published
2021-10-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
KZDInfusor, Pressure, For I.V. Bags

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KZDInfusor, Pressure, For I.V. BagsGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
96973521872067PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
9697352187206796973521872067

GMDN Terms#

Term, Definition table
TermDefinition
Intravenous pressure infusor, automatedA pneumatically-powered device designed to increase the rate of an intravenous (IV) infusion given to a patient by applying pressure directly to the infusion bag. The device is designed with a pressure chamber into which the infusion bag is secured, and is connected to a supply of pressurized air which, when activated, creates pressure in the rear of the chamber. It typically includes a pressure gauge to indicate the applied pressure and overpressure safety features.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
544328369
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
96973521872753N/AM2023-06-12
96973521872777N/AL2023-06-12
96973521872272N/AVT-1212023-05-31
96973521872289N/AVT-1222023-05-31
96973521872296N/AVT-1232023-05-31
96973521872302N/AVT-1242023-05-31
96973521872319N/AVT-1252023-05-31
96973521872326N/AVT-1262023-05-31
96973521872333N/AVT-1272023-05-31
96973521872340N/AVT-1282023-05-31
96973521872357N/AVT-1182023-05-31
96973521872418N/AVT-1112023-05-31
96973521872425N/AVT-1122023-05-31
96973521872432N/AVT-1132023-05-31
96973521872449N/AVT-1142023-05-31
96973521872456N/AVT-1152023-05-31
96973521872463N/AVT-1162023-05-31
96973521872470N/AVT-1172023-05-31
96973521870476VistarmedVC-022022-12-23
96973521870483VistarmedVC-032022-12-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00199536933705BluelineTransparent Supply Solutions Ltd.KZD2026-05-15
00199536933712BluelineTransparent Supply Solutions Ltd.KZD2026-05-15
00199536933729BluelineTransparent Supply Solutions Ltd.KZD2026-05-15
00199536933736BluelineTransparent Supply Solutions Ltd.KZD2026-05-15
00199536933743BluelineTransparent Supply Solutions Ltd.KZD2026-05-15
00199536933750BluelineTransparent Supply Solutions Ltd.KZD2026-05-15
00199536933767BluelineTransparent Supply Solutions Ltd.KZD2026-05-15
00199536933774BluelineTransparent Supply Solutions Ltd.KZD2026-05-15
00810132043789HCSConcordance Healthcare Solutions LLCKZD2026-05-13
00810132043796HCSConcordance Healthcare Solutions LLCKZD2026-05-13
00810132043680HCSConcordance Healthcare Solutions LLCKZD2025-10-23
00810132043697HCSConcordance Healthcare Solutions LLCKZD2025-10-23
00810132043703HCSConcordance Healthcare Solutions LLCKZD2025-10-23
10889483600962Vital Signs™AIRLIFEKZD2025-07-31
10889483600986Vital Signs™AIRLIFEKZD2025-07-31
10889483600993Vital Signs™AIRLIFEKZD2025-07-31
10889483601013Vital Signs™AIRLIFEKZD2025-07-31
10889483601037Vital Signs™AIRLIFEKZD2025-07-31
10889483642368Vital Signs™SUNMED, LLCKZD2025-07-31
10889483642382Vital Signs™SUNMED, LLCKZD2025-07-31
10889483642405Vital Signs™SUNMED, LLCKZD2025-07-31
00816317024277Medline Pressure Infuser Bag 1000mlRENU MEDICAL, INCKZD2024-12-02
00811220035488PremierProPRESTIGE AMERITECH, LTD.KZD2024-10-28
00811220035501PremierProPRESTIGE AMERITECH, LTD.KZD2024-10-28
10889483230770InfuseOneETHOX MEDICAL, LLCKZD2024-07-01
10889483230787InfuseOneETHOX MEDICAL, LLCKZD2024-07-01
10193489033106MedlineMEDLINE INDUSTRIES, INC.KZD2024-01-16
10193489033113MedlineMEDLINE INDUSTRIES, INC.KZD2024-01-16
10197344020508MedlineMEDLINE INDUSTRIES, INC.KZD2023-12-21
00816317022372Vital SignsRENU MEDICAL, INCKZD2023-06-27