FDA.reportPublic FDA data

Vacuette

Primary DI
29120049205015
Brand
Vacuette
Company
Greiner Bio-One GmbH
Model
450062
Catalog number
450062
Device description
"VACUETTE® Multiple Use Drawing Needle 21G x 1 1/4"" green, sterile, not made with natural rubber latex 0.8 x 32 mm"
Published
2018-07-10
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
K973620000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K973620000VACUETTE MULTI-SAMPLE NEEDLEGreiner Meditech, Inc.1997-12-17FMI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
39120049205012PackageGS120In Commercial Distribution
49120049205019PackageGS13In Commercial Distribution
29120049205015PrimaryGS10
19120049205018Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3912004920501239120049205012
4912004920501949120049205019
2912004920501529120049205015
1912004920501819120049205018

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature4 Degrees Celsius36 Degrees Celsius

Regulatory Flags#

DUNS number
303639066
Device count
100
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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Primary DI, Brand, Company table
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08056999020347SurTract™RONCADELLE OPERATIONS SRLFMI2026-05-31
08056999020354SurTract™RONCADELLE OPERATIONS SRLFMI2026-05-31
08056999020361SurTract™RONCADELLE OPERATIONS SRLFMI2026-05-31
08056999020385SurTract™RONCADELLE OPERATIONS SRLFMI2026-05-31
08056999020408SurTract™RONCADELLE OPERATIONS SRLFMI2026-05-31
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08586015044847CHIRAVACCHIRANA T.Injecta, a. s.FMI2026-04-27
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08586015044861CHIRAVACCHIRANA T.Injecta, a. s.FMI2026-04-27