FDA.reportPublic FDA data

Maveric Medical

Primary DI
10850028131012
Brand
Maveric Medical
Company
MAVERIC MEDICAL LLC
Model
M6230
Device description
Blood Collection Set, Safety, 23G x 3/4", 7" Tubing, Luer Adapter
Published
2021-09-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
JKATubes, Vials, Systems, Serum Separators, Blood Collection

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JKATubes, Vials, Systems, Serum Separators, Blood CollectionClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K172763000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K172763000Blood Collecting Needle, Safety Blood Collecting Needle, Blood Collecting Needle with Holder, Safety Blood Collecting Needle with Holder, Blood Collecting Set, Safety Blood Collecting Set, Blood Collecting Set with Holder, Safety Blood Collecting Set with HolderZhejiang Kindly Medical Devices Co., Ltd.2018-06-04JKA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850028131012PackageGS150In Commercial Distribution
20850028131019PackageGS11000In Commercial Distribution
00850028131015PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085002813101210850028131012
2085002813101920850028131019
00850028131015008500281310158500281310150850028131015

GMDN Terms#

Term, Definition table
TermDefinition
Blood collection set, invasiveA collection of devices intended to be used by a healthcare professional, in combination with evacuated blood collection tubes, for the routine collection of multiple blood specimens from a patient, via one venipuncture, for clinical analyses. It consists of a blood collection needle or venous butterfly/scalp vein needle and additional devices that may include tubing, male/female Luer-lock connectors, clamps, and a blood collection tube holder. Blood access is directly through the vein with the needle. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
117229530
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
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00085002813100Maveric Medical M62102021-07-29
00085002813117Maveric Medical M62302021-07-29
00085002813124Maveric MedicalM62502021-07-29
00085002813131Maveric MedicalM62142021-07-29
00085002813148Maveric MedicalM62342021-07-29
00085002813155Maveric MedicalM62542021-07-29
00085002813162Maveric MedicalM62172021-07-29
00085002813179Maveric MedicalM62372021-07-29
00085002813186Maveric MedicalM62572021-07-29
00085002813193Maveric MedicalM62162021-07-29
00850028131008Maveric Medical M62102021-09-24
00850028131015Maveric Medical M62302021-09-24
00850028131022Maveric MedicalM62502021-09-24
00850028131039Maveric MedicalM62142021-09-24
00850028131046Maveric MedicalM62342021-09-24
00850028131053Maveric MedicalM62542021-09-24
00850028131060Maveric MedicalM62172021-09-24
00850028131077Maveric MedicalM62372021-09-24
00850028131084Maveric MedicalM62572021-09-24
00850028131091Maveric MedicalM62162021-09-24

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Primary DI, Brand, Company table
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