Worksafe™ Blood Culture Collection Kits: FAN®PLUS Pediatric

GUDID 03573026601898

BacT/ALERT Worksafe Collection Kit contains most of the items to facilitate blood culture collection. This kit contains FA Plus Pediatric Bottle.

BIOMERIEUX , INC.

Blood culture broth kit IVD Blood culture broth kit IVD Blood culture broth kit IVD Blood culture broth kit IVD Blood culture broth kit IVD Blood culture broth kit IVD Blood culture broth kit IVD Blood culture broth kit IVD Blood culture broth kit IVD Blood culture broth kit IVD Blood culture broth kit IVD Blood culture broth kit IVD Blood culture broth kit IVD Blood culture broth kit IVD Blood culture broth kit IVD Blood culture broth kit IVD
Primary Device ID03573026601898
NIH Device Record Key36d0246f-2720-45ad-87e0-68b3024aa300
Commercial Distribution StatusIn Commercial Distribution
Brand NameWorksafe™ Blood Culture Collection Kits: FAN®PLUS Pediatric
Version Model NumberWorksafe™ Blood Culture Collection Kits: FAN®PLUS
Company DUNS086785110
Company NameBIOMERIEUX , INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS103573026601898 [Package]
Contains: 03573026606480
Package: [20 Units]
In Commercial Distribution
GS103573026606480 [Primary]

FDA Product Code

OIBBlood and urine collection kit (excludes HIV testing)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-05-01
Device Publish Date2020-04-23

Devices Manufactured by BIOMERIEUX , INC.

03573026636357 - VITEK® 2 AST-N8142023-12-14 VITEK® 2 Gram Negative Susceptibility Card is intended for use with the VITEK 2 Systems to determine the susceptibility of clin
03573026635978 - VITEK® 2 AST-N8092023-11-10 VITEK® 2 Gram Negative Susceptibility Card is intended for use with the VITEK 2 Systems to determine the susceptibility of clin
03573026636142 - VITEK® 2 AST-N8112023-11-10 VITEK® 2 Gram Negative Susceptibility Card is intended for use with the VITEK 2 Systems to determine the susceptibility of clin
03573026636296 - VITEK® 2 AST-N8122023-11-10 VITEK® 2 Gram Negative Susceptibility Card is intended for use with the VITEK 2 Systems to determine the susceptibility of clin
03573026636319 - VITEK® 2 AST-N8132023-11-10 VITEK® 2 Gram Negative Susceptibility Card is intended for use with the VITEK 2 Systems to determine the susceptibility of clin
03573026636333 - VITEK® 2 AST-XN332023-11-10 VITEK® 2 Gram Negative Susceptibility Card is intended for use with the VITEK 2 Systems to determine the susceptibility of clin
03573026636128 - VITEK® 2 AST-N8102023-11-09 VITEK® 2 Gram Negative Susceptibility Card is intended for use with the VITEK 2 Systems to determine the susceptibility of clin
03573026636067 - VITEK® 2 AST-N8042023-10-04 VITEK® 2 Gram Negative Susceptibility Card is intended for use with the VITEK 2 Systems to determine the susceptibility of clin

Trademark Results [Worksafe]

Mark Image

Registration | Serial
Company
Trademark
Application Date
WORKSAFE
WORKSAFE
90354894 not registered Live/Pending
Vincent David Mims
2020-12-02
WORKSAFE
WORKSAFE
90027521 not registered Live/Pending
KUTIR MOBILITY
2020-06-30
WORKSAFE
WORKSAFE
90004858 not registered Live/Pending
Connecting World Merchandise, LLC
2020-06-16
WORKSAFE
WORKSAFE
88945612 not registered Live/Pending
Pointr Limited
2020-06-03
WORKSAFE
WORKSAFE
88258419 not registered Live/Pending
BSB PARTICIPAÇÕES S.A.
2019-01-11
WORKSAFE
WORKSAFE
88241142 not registered Dead/Abandoned
Emergency University, Inc.
2018-12-25
WORKSAFE
WORKSAFE
87574631 5423384 Live/Registered
Innate Devices, LLC
2017-08-18
WORKSAFE
WORKSAFE
86630453 5191831 Live/Registered
Western Oilfields Supply Company
2015-05-14
WORKSAFE
WORKSAFE
86422116 4747673 Live/Registered
Builders Mutual Insurance Company
2014-10-13
WORKSAFE
WORKSAFE
86357938 not registered Dead/Abandoned
BSB PARTICIPAÇÕES S/A
2014-08-05
WORKSAFE
WORKSAFE
86148426 not registered Dead/Abandoned
Worksafeusa LLC
2013-12-19
WORKSAFE
WORKSAFE
77881167 not registered Dead/Abandoned
Starnet Technologies, Inc.
2009-11-25

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.