FDA.reportPublic FDA data

VACUTEST KIMA S.R.L.

Primary DI
28053848993009
Brand
VACUTEST KIMA S.R.L.
Company
MEUS SRL
Model
15181
Catalog number
15181
Device description
STERILE SINGLE-SAMPLE NEEDLES 18 G X 1"-PINK
Published
2023-09-06
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
28053848993009PackageGS11000In Commercial Distribution
38053848993006PackageGS16000In Commercial Distribution
18053848993002PrimaryGS10
08053848993005Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
2805384899300928053848993009
3805384899300638053848993006
1805384899300218053848993002
08053848993005080538489930058053848993005

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
Needle Gauge18Gauge

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
100
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
18053848992999VACUTEST KIMA S.R.L.15176151762023-09-06
18053848993002VACUTEST KIMA S.R.L.15181151812023-09-06
18053848993019VACUTEST KIMA S.R.L.15193151932023-09-06
18053848993026VACUTEST KIMA S.R.L.15201152012023-09-06
18053848993033VACUTEST KIMA S.R.L.15213152132023-09-06
18053848993040VACUTEST KIMA S.R.L.15225152252023-09-06
18053848993057VACUTEST KIMA S.R.L.152650215265022023-09-06
18053848993064VACUTEST KIMA S.R.L.152650415265042023-09-06
18053848993071VACUTEST KIMA S.R.L.15265062023-09-06
28053848992996VACUTEST KIMA S.R.L.15176151762023-09-06
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
18053848992814VACUTEST KIMA S.R.L.155202023-09-05
18053848992821VACUTEST KIMA S.R.L.15521155212023-09-05
18053848992838VACUTEST KIMA S.R.L.15522155222023-09-05

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