FDA.reportPublic FDA data

Micro pipette, plastic EDTA

Primary DI
07350040790250
Brand
Micro pipette, plastic EDTA
Company
Boule Medical AB
Model
Micro pipette, plastic EDTA 1x100
Catalog number
1070039
Device description
Accessory for the MPA use in Medonic M-series, Swelab Alfa-series, and Boule 950-series hematology analyzer for blood collection from a finger stick or a venous blood sample and direct insertion into the Micro Pipette Adapter (MPA) inlet of Medonic M-series, Swelab Alfa-series, and Boule 950-series automated hematology analyzers.
Published
2024-10-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GIOTube, Collection, Capillary Blood

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GIOTube, Collection, Capillary BloodHematology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07350040790250PackageGS110In Commercial Distribution
07350040790687PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07350040790250073500407902507350040790250
07350040790687073500407906877350040790687

GMDN Terms#

Term, Definition table
TermDefinition
Capillary blood transfer tube IVD, EDTAA non-sterile glass or plastic capillary blood transfer tube coated internally with the anticoagulant ethylenediaminetetraacetic acid (EDTA), and intended to be attached to a non-evacuated blood collection tube to assist with the transfer of blood drops from the blood collection site into the collection tube using a capillary action. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1800-453-3328qualitygroup@boule.com

Regulatory Flags#

DUNS number
354417933
Device count
1
DM exempt
false
Premarket exempt
true
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
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07350040790687Micro pipette, plastic EDTAMicro pipette, plastic EDTA 1x10010700392024-10-04
07350040791417Boule EasyCleanerBoule EasyCleaner, 50ml15045132024-10-04
07350040796399Medonic M51-D DiluentMedonic M51-D Diluent, 20L15045102024-10-04
07350040796405Medonic M51-L1 LyseMedonic M51-L1 Lyse, 200mL15045112024-10-04
07350040796412Medonic M51-L2 LyseMedonic M51-L2 Lyse, 500mL15045122024-10-04
07350040796429Swelab Lumi-D DiluentSwelab Lumi-D Diluent 20L15045142024-10-04
07350040796436Swelab Lumi-L1 LyseSwelab Lumi-L1 Lyse 200mL15045152024-10-04
07350040796443Swelab Lumi-L2 LyseSwelab Lumi-L2 Lyse, 500mL15045162024-10-04
07350040796344Medonic M-seriesM16 US14001062016-09-17
07350040796351Medonic M-seriesM16M US140000732016-09-17
07350040796368Medonic M-seriesM16C US14000742016-09-17
07350040796375Medonic M-seriesM16S BD ABR US14000752016-09-17

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