FDA.reportPublic FDA data

VACUTEST KIMA S.R.L.

Primary DI
28053848992842
Brand
VACUTEST KIMA S.R.L.
Company
MEUS SRL
Model
15565
Device description
STERILE NEEDLES W/SAFETY DEVICE 20G X1" YELLOW
Published
2023-09-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FMINeedle, Hypodermic, Single Lumen

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMINeedle, Hypodermic, Single LumenGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
28053848992842PackageGS125In Commercial Distribution
38053848992849PackageGS1200In Commercial Distribution
18053848992845PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2805384899284228053848992842
3805384899284938053848992849
1805384899284518053848992845

GMDN Terms#

Term, Definition table
TermDefinition
Non-fixed blood collection needleA sharp bevel-edged, hollow tubular metal instrument intended to be used as part of a blood collection set for drawing blood from a patient; it does not include wings for fixation/placement (i.e., not a venous butterfly/scalp vein needle). It is intended to be connected to blood collection tubing and/or a blood collection Luer connector for transfer into a blood specimen receptacle. It may include a pre-attached blood collection tube spike and/or a safety cover; however, it does not include blood collection tubing or a tube holder (i.e., not a set). This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length25Millimeter
Needle Gauge20Gauge

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature5 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+390499719511info@vacutestkima.it

Regulatory Flags#

DUNS number
514346550
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
true
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
28053848992996VACUTEST KIMA S.R.L.15176151762023-09-06
28053848993009VACUTEST KIMA S.R.L.15181151812023-09-06
28053848993016VACUTEST KIMA S.R.L.15193151932023-09-06
28053848993023VACUTEST KIMA S.R.L.15201152012023-09-06
28053848993030VACUTEST KIMA S.R.L.15213152132023-09-06
28053848993047VACUTEST KIMA S.R.L.15225152252023-09-06
28053848993054VACUTEST KIMA S.R.L.152650215265022023-09-06
28053848993061VACUTEST KIMA S.R.L.152650415265042023-09-06
28053848993078VACUTEST KIMA S.R.L.15265062023-09-06
28053848992811VACUTEST KIMA S.R.L.155202023-09-05
28053848992828VACUTEST KIMA S.R.L.15521155212023-09-05
28053848992835VACUTEST KIMA S.R.L.15522155222023-09-05
28053848992859VACUTEST KIMA S.R.L.15566155662023-09-05
28053848992866VACUTEST KIMA S.R.L.15567155672023-09-05
28053848992989VACUTEST KIMA S.R.L.15164151642023-09-05

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Primary DI, Brand, Company table
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