FDA.reportPublic FDA data

Vacuette

Primary DI
19120049207487
Brand
Vacuette
Company
Greiner Bio-One GmbH
Model
450210
Catalog number
450210
Device description
VACUETTE® SAFELINK Holder with male luer lock single-packed, not made with natural rubber latex
Published
2018-11-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FMINeedle, hypodermic, single lumen

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K180545000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K180545000VACUETTE SAFELINK Holder with male luer lockGreiner Bio-One Na, Inc.2018-05-21FMI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
29120049207484PackageGS1100In Commercial Distribution
39120049207481PackageGS18In Commercial Distribution
19120049207487PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2912004920748429120049207484
3912004920748139120049207481
1912004920748719120049207487

GMDN Terms#

Term, Definition table
TermDefinition
Luer-ended blood collection tube spikeA device intended to be used during patient blood collection to facilitate transfer of a clinical blood specimen from blood collection tubing or a needle to a blood specimen receptacle (e.g., evacuated blood collection tube, adapted syringe). It is designed to be fitted to a blood collection tube holder, where it connects to the tubing or needle via a Luer connection at one end, and penetrates an evacuated blood collection tube at the other end for blood collection. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature4 Degrees Celsius25 Degrees Celsius

Regulatory Flags#

DUNS number
303639066
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
19120126131421VACUETTE4530494530492026-01-26
19120126131407VACUETTE4530474530472026-01-26
19120126131414VACUETTE4530484530482026-01-26
19120126131469VACUETTE4530464530462026-01-26
29120126131404VACUETTE4530474530472026-01-26
29120126131411VACUETTE4530484530482026-01-26
29120126131428VACUETTE4530494530492026-01-26
29120126131466VACUETTE4530464530462026-01-26
29120017577656Vacuette4588154588152020-09-24
19120126131452VACUETTE4530454530452025-04-02
29120126131459VACUETTE4530454530452025-04-02
29120049209310Vacuette4560084560082025-03-25
29120049209327Vacuette4550244550242025-03-25
29120049209334Vacuette4550234550232025-03-25
39120049209317Vacuette4560084560082025-03-25
39120049209324Vacuette4550244550242025-03-25
39120049209331Vacuette4550234550232025-03-25
19120126131001VACUETTE7243257243252024-07-23
29120126131008VACUETTE7243257243252024-07-23
29120049204605Vacuette455232P455232P2016-09-23

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