FDA.reportPublic FDA data

Vacuette

Primary DI
39120017570074
Brand
Vacuette
Company
Greiner Bio-One GmbH
Model
450042
Catalog number
450042
Device description
VACUETTE® VISIO PLUS Needle 21G x 1" green, sterile, not made with natural rubber latex 0.8 x 25 mm
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
K061483000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K061483000VACUETTE VISIO PLUS BLOOD COLLECTION NEEDLESGreiner Bio-One North America, Inc.2006-08-14FMI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
39120017570074PackageGS120In Commercial Distribution
49120017570071PackageGS13In Commercial Distribution
29120017570077PrimaryGS10
19120017570070Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3912001757007439120017570074
4912001757007149120017570071
2912001757007729120017570077
1912001757007019120017570070

GMDN Terms#

Term, Definition table
TermDefinition
Blood collection needleA sterile, 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 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 however it does not include a blood collection tube holder. This is a single-use device.

Storage And Handling#

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

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
303639066
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
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

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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