FDA.report

VACUTEST KIMA S.R.L.

Primary DI
28053848992811
Brand
VACUTEST KIMA S.R.L.
Company
MEUS SRL
Model
15520
Device description
STERILE SAFETY NEEDLES 20G X 1 1/2" 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

Related Records

Contact Domains

Product Codes

CodeName
FMINeedle, Hypodermic, Single Lumen

Product Code Classifications

CodeDeviceSpecialtyClass
FMINeedle, Hypodermic, Single LumenGeneral Hospital2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
28053848992811PackageGS125In Commercial Distribution
38053848992818PackageGS1200In Commercial Distribution
18053848992814PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
2805384899281128053848992811
3805384899281838053848992818
1805384899281418053848992814

GMDN Terms

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

TypeValueUnit
Length38Millimeter
Needle Gauge20Gauge

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature5 Degrees Celsius25 Degrees Celsius

Sterilization Methods

Method

Contacts

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 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
28053848992828VACUTEST KIMA S.R.L.15521155212023-09-05
28053848992835VACUTEST KIMA S.R.L.15522155222023-09-05
28053848992842VACUTEST KIMA S.R.L.155652023-09-05
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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