Atlas FDA

EVA EMPTY SOLUTION CONTAINER

FDA 510(k) clearance K030888 · decided 2003-04-02

Clearance details

K-number
K030888
Device name
EVA EMPTY SOLUTION CONTAINER
Applicant
Metrix Co.
Decision
Substantially Equivalent
Date received
2003-03-21
Decision date
2003-04-02
Days to decision
12 days
Clearance type
Special
Product code
KPE
Device class
2
Regulation number
880.5025
Medical specialty
General Hospital
Advisory committee
General Hospital
Location
Dubuque, IA, US
Third-party review
No
Expedited review
No

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DMRX 100ml Empty Container Solution; DMRX 250ml Empty Container Solution; DMRX 500ml Empty Container Solution; DMRX 1000ml Empty Container Solution (K250459)Technoflex Sas.2025-04-18
eZSURE™ Empty Fluid Container with ProSeal™ Injection Site (K241442)Epic Medical Pte. , Ltd.2024-06-21
eZSURE™ Empty Fluid Container (models 426030, 426040, 426110) (K223674)Epic Medical Pte. , Ltd.2023-09-01
Disposable Infusion Bag for Parenteral Nutrition (K222622)Beijing L&Z Medical Technology Development Co., Ltd.2023-02-16
Empty EVA Bag (K210749)Haemotronic S.P.A.2021-08-19
SmartSite Bag 500mL, SmartSite Bag 250 mL, SmartSite Bag 100 mL (K201936)Gilero, LLC2021-05-06
Empty EVA Bag (K193528)Haemotronic S.P.A.2020-07-22
HCT Empty EVA Container Pack (K190328)Health Care Technologies2019-08-15

Recalls involving this device

RecordFirmDate
VYGON 100 mL EMPTY EVA CONTAINER With 2 Ports, REF CMS-9601; An empty single-use pouch mad recall (Z-0330-2025)The Metrix Company2024-11-08
VYGON 250 mL EMPTY EVA CONTAINER With 2 Ports, REF CMS-9602; An empty single-use pouch mad recall (Z-0331-2025)The Metrix Company2024-11-08
CORMIX 150 mL EMPTY EVA CONTAINER With 2 Ports, REF MS64040; An empty single-use pouch mad recall (Z-0332-2025)The Metrix Company2024-11-08
CORMIX 250 mL EMPTY EVA CONTAINER With 2 Ports, REF MS64045; An empty single-use pouch mad recall (Z-0333-2025)The Metrix Company2024-11-08
CORMIX 500 mL EMPTY EVA CONTAINER With 2 Ports, REF MS64050; An empty single-use pouch mad recall (Z-0334-2025)The Metrix Company2024-11-08
SECURE 100 mL EMPTY EVA CONTAINER With 2 Ports, REF 66040; An empty single-use pouch made recall (Z-0335-2025)The Metrix Company2024-11-08
SECURE 100 mL EMPTY EVA CONTAINER With 2 Ports (Bulk Packed), REF 66041; An empty single-u recall (Z-0336-2025)The Metrix Company2024-11-08
SECURE 50 mL EMPTY EVA CONTAINER With 2 Ports, REF 66042; An empty single-use pouch made o recall (Z-0337-2025)The Metrix Company2024-11-08
SECURE 50 mL EMPTY EVA CONTAINER With 2 Ports (Bulk Packed) , REF 66043; An empty single-u recall (Z-0338-2025)The Metrix Company2024-11-08
SECURE 250 mL EMPTY EVA CONTAINER With 2 Ports, REF 66045; An empty single-use pouch made recall (Z-0339-2025)The Metrix Company2024-11-08
SECURE 500 mL EMPTY EVA CONTAINER With 2 Ports, REF 66050; An empty single-use pouch made recall (Z-0340-2025)The Metrix Company2024-11-08
SECURE 1000 mL EMPTY EVA CONTAINER With 2 Ports, REF 66055; An empty single-use pouch made recall (Z-0341-2025)The Metrix Company2024-11-08
Imed Products Imed EVA BAG, 150 mL, 2-PORTS, REF IM38040; An empty single-use pouch made o recall (Z-0342-2025)The Metrix Company2024-11-08
Imed Products Imed EVA BAG, 250 mL, 2-PORTS, REF IM68045; An empty single-use pouch made o recall (Z-0343-2025)The Metrix Company2024-11-08
Imed Products Imed EVA BAG, 500 mL, 2-PORTS, REF IM68050; An empty single-use pouch made o recall (Z-0344-2025)The Metrix Company2024-11-08
Imed Products Imed EVA BAG, 1000 mL, 2-PORTS, REF IM68055; An empty single-use pouch made recall (Z-0345-2025)The Metrix Company2024-11-08