FDA.reportPublic FDA data

HydroMID Basic Kit

Primary DI
00850030354341
Brand
HydroMID Basic Kit
Company
Access Vascular, Inc.
Model
80H04102
Catalog number
80H04102
Device description
Midline Marked Catheter (Basic Kit)
Published
2023-12-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FOZCatheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FOZCatheter, Intravascular, Therapeutic, Short-Term Less Than 30 DaysGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K220772000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K220772000HydroMID 4F Single Lumen Midline CatheterAccess Vascular, Inc.2022-12-07FOZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850030354341PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850030354341008500303543418500303543410850030354341

GMDN Terms#

Term, Definition table
TermDefinition
General surgical procedure kit, medicatedA typically non-dedicated collection of various surgical instruments, sometimes with dressings and/or other materials, and that includes a pharmaceutical component, intended to be used during: 1) open abdominal surgery; 2) a range of open surgical procedures across multiple clinical specialties (non-dedicated); 3) non-orthopaedic trauma surgery; 4) minor dermatological surgery; or 5) cosmetic surgery below the head. As a kit that includes procedural devices, it is neither dedicated to surgical scrubbing, surgical patient preparation, nor anaesthesia, and is not a dedicated biopsy kit. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
085539114
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850030354167HydroMID80H061022025-11-18
00850030354174HydroMID80H061042025-11-18
00850030354426HydroMID MID-2512025-11-18
00850030354433HydroMID900061042025-11-18
00850030354471HydroPICCPICC-2522025-11-18
00850030354501HydroPICC80H021412025-11-18
00850030354518HydroPICC80H021422025-11-18
00850030354525HydroPICC80H021442025-11-18
00850030354396HydroPICC90001104900011042024-06-04
00850030354402HydroPICC Dual Lumen90002104900021042024-06-04
00850030354419HydroMID90004104900041042024-06-04
00850030354204HydroMID Basic Kit80004102800041022022-12-20
00850030354211HydroMID Maximal Barrier Kit80004104800041042022-12-20
00850030354280HydroPICC Basic Kit (130cm GW)80H0110180H011012023-12-19
00850030354297HydroPICC Basic Kit (70cm GW)80H0110280H011022023-12-19
00850030354310HydroPICC Dual Lumen 80H0210180H021012023-12-19
00850030354327HydroPICC Dual Lumen 80H0210280H021022023-12-19
00850030354303HydroPICC Maximal Barrier Kit80H0110480H011042023-11-30
00850030354334HydroPICC Dual Lumen 80H0210480H021042023-11-30
00850030354358HydroMID Maximal Barrier Kit80H0410480H041042023-11-30

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