FDA.reportPublic FDA data

Ethox

Primary DI
10889483084311
Brand
Ethox
Company
ETHOX MEDICAL, LLC
Model
VC405
Catalog number
VC405
Device description
500 ml Disposable Pressure Infuser
Published
2023-03-21
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Safe
Rx
true
Single use
true

Contact Domains#

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
10889483084311PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088948308431110889483084311

GMDN Terms#

Term, Definition table
TermDefinition
Intravenous pressure infusor, manual, reusableA manually-operated device designed to increase/control the rate of an intravenous (IV) solution given to a patient by manually applying pressure directly to the infusion bag. It is typically a flexible inflatable bag/cuff with a pocket to hold the infusion bag; it may include a squeeze bulb, mechanical screw, or spring mechanism to create the pressure. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume500Milliliter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)433-2797info@sun-med.com

Regulatory Flags#

DUNS number
079149179
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
20889483160081EthoxVC505VC5052023-03-21
20889483160098EthoxVC510VC5102023-03-21
20889483160104EthoxVC530VC5302023-03-21
20889483149703Ethox9500890009500890002023-03-21
20889483149741Ethox9500893009500893002023-03-21
20889483149758Ethox9500894009500894002023-03-21
20889483149765Ethox9500895009500895002023-03-21
20889483149772Ethox9500896009500896002023-03-21
20889483149970Ethox9500931009500931002023-03-21
20889483149994Ethox9500935009500935002023-03-21
10889483130964Ethox Medical4500814002016-09-28
10889483131138Ethox Medical4500874002016-09-29
10889483131145Ethox Medical4500875002016-09-29
10889483150030Ethox Medical9500942012016-09-27
10889483149782Ethox Medical9500897002016-09-29
10889483110072EthoxVC410VC4102023-03-21
10889483110782EthoxVC430VC4302023-03-21
20889483149710Ethox9500891009500891002023-03-21
20889483149727Ethox9500892009500892002023-03-21
10889483230770InfuseOne42357-0142357-012024-07-01

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