FDA.report

VACUETTE

Primary DI
39120049206606
Brand
VACUETTE
Company
Greiner Bio-One GmbH
Model
450127
Catalog number
450127
Device description
VACUETTE® EVOPROTECT SAFETY Blood Collection Set + Luer Adapter 21G x 3/4" tubing length 7 1/2" (19 cm), single-packed, sterile, not made with natural rubber latex or DEHP
Published
2020-03-03
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

Product Codes

CodeName
FMINeedle, hypodermic, single lumen

Product Code Classifications

CodeDeviceSpecialtyClass
FMINeedle, Hypodermic, Single LumenGeneral Hospital2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
29120049206609PackageGS160In Commercial Distribution
39120049206606PackageGS118In Commercial Distribution
19120049206602PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
2912004920660929120049206609
3912004920660639120049206606
1912004920660219120049206602

GMDN Terms

TermDefinition
Venous butterfly needle/setAn invasive device/collection of devices which includes a sharp and rigid needle intended to puncture a vein to collect blood and/or for transient (<24 hours) administration of intravenous (IV) fluids. The needle includes wings for fixation/placement and may include tubing/connectors; it is not, and does not include, a peripheral catheter. The device may be referred to as a butterfly needle or scalp vein needle. This is a single-use device.

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature4 Degrees Celsius25 Degrees Celsius

Sterilization Methods

Method

Regulatory Flags

DUNS number
303639066
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

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