FDA.reportPublic FDA data

Vacuette

Primary DI
39120049208617
Brand
Vacuette
Company
Greiner Bio-One GmbH
Model
724321
Catalog number
724321
Device description
Urine Cup with integrated Transfer Device 100 ml bulk-packed, sterile
Published
2022-06-18
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

Product Codes#

Code, Name table
CodeName
FMHCONTAINER, SPECIMEN, STERILE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMHContainer, Specimen, SterilePathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
39120049208617PackageGS1300In Commercial Distribution
19120049208613PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3912004920861739120049208617
1912004920861319120049208613

GMDN Terms#

Term, Definition table
TermDefinition
General specimen container IVD, no additive/mediumAn empty covered receptacle containing no additives or media intended to be used for the collection, and preservation and/or transport, of more than one type of clinical specimen (e.g., urine, faeces, sputum, mucous, tissue) derived from different body regions for in vitro diagnostic investigation. It does not contain patient-contact specimen sampling/extraction devices such as swabs/brushes. This is a single-use device.

Storage And Handling#

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

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
303639066
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
false
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
29120126131404VACUETTE4530474530472026-01-26
29120126131411VACUETTE4530484530482026-01-26
29120126131428VACUETTE4530494530492026-01-26
29120126131466VACUETTE4530464530462026-01-26
29120126131459VACUETTE4530454530452025-04-02
39120049209317Vacuette4560084560082025-03-25
39120049209324Vacuette4550244550242025-03-25
39120049209331Vacuette4550234550232025-03-25
29120126131008VACUETTE7243257243252024-07-23
39120126131012VACUETTE455043P455043P2024-07-02
39120126130978VACUETTE484493P484493P2024-05-14
39120126130985VACUETTE486073P486073P2024-05-14
39120126130992VACUETTE4860894860892024-05-14
39120017577172Vacuette4845074845072023-12-15
39120017579374Vacuette4845184845182023-12-15
39120049208143Vacuette4845284845282023-12-15
29120049209952Vacuette450161V1450161V12023-12-11
29120049208719Vacuette450081V1450081V12023-12-07
29120049208726Vacuette450082V1450082V12023-12-07
29120049208740Vacuette450084V1450084V12023-12-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
16970462546716Broncho SamplerShenzhen HugeMed Medical Technical Development Co., Ltd.FMH2026-02-10
H1084306553CorningCorning IncorporatedFMH2026-01-26
H1083540143Falcon A Corning BrandCorning IncorporatedFMH2026-01-23
H1083540173Falcon A Corning BrandCorning IncorporatedFMH2026-01-23
H1083540203Falcon A Corning BrandCorning IncorporatedFMH2026-01-23
H108117393CorningCorning IncorporatedFMH2026-01-14
30815112021475Transpec Specimen Radiography DeviceBracco Diagnostics Inc.FMH2026-01-09
30815112021482TranspecBracco Diagnostics Inc.FMH2026-01-09
00810124536923Avaline Medical NJ LLCAvaline Medical NJ Limited Liability CompanyFMH2025-12-05
40198459304638MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.FMH2025-08-18
40198459382964MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.FMH2025-07-02
20816203023913O-Wrap™ BagORIGEN BIOMEDICAL, INC.FMH2025-06-18
20816203024019TissueVault™ Cell & Tissue Freezing BagORIGEN BIOMEDICAL, INC.FMH2025-06-18
20816203024095O-Wrap™ BagORIGEN BIOMEDICAL, INC.FMH2025-06-18
20816203024156TissueVault™ Cell & Tissue Freezing BagORIGEN BIOMEDICAL, INC.FMH2025-06-18
40080196035299MEDLINEMEDLINE INDUSTRIES, INC.FMH2025-06-12
40884389226262MEDLINEMEDLINE INDUSTRIES, INC.FMH2025-06-12
40888277117922MEDLINEMEDLINE INDUSTRIES, INC.FMH2025-06-12
40198459351328MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.FMH2025-06-02
00840165500300Leakbuster 3Starplex Scientific Corp.FMH2025-05-28
00840165500324Leakbuster 3Starplex Scientific Corp.FMH2025-05-28
00840165500362LeakbusterStarplex Scientific Corp.FMH2025-05-28
00840165500485LeakbusterStarplex Scientific Corp.FMH2025-05-28
00840165500508LeakbusterStarplex Scientific Corp.FMH2025-05-28
00840165500058LeakbusterStarplex Scientific Corp.FMH2025-05-28
00840165500072StarCLICK 100Starplex Scientific Corp.FMH2025-05-28
00840165500294Leakbuster 3Starplex Scientific Corp.FMH2025-05-28
00840165500355LeakbusterStarplex Scientific Corp.FMH2025-05-28
00840165500393LeakbusterStarplex Scientific Corp.FMH2025-05-28
00840165500454LeakbusterStarplex Scientific Corp.FMH2025-05-28