FDA.reportPublic FDA data

Advanced Instruments Palladox Disposable Satchet

Primary DI
00816068020962
Brand
Advanced Instruments Palladox Disposable Satchet
Company
Advanced Instruments, LLC
Model
AN3146
Catalog number
AN3146
Device description
The new single use Palladox disposable sachet is designed specifically to work with the Anoxomat System. The easy-to-use, single-use catalyst will simplify your anaerobic sample testing by minimizing catalyst handling time. The Palladox sachet reduces the oxygen in the jar in minutes and maintains an anaerobic environment for the duration of incubation. This product is the perfect solution to improve workflow efficiency, eliminate downtime and simplify anaerobic testing.
Published
2020-09-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KZJDevice, Gas Generating

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KZJDevice, Gas GeneratingMicrobiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816068020962PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816068020962008160680209628160680209620816068020962

GMDN Terms#

Term, Definition table
TermDefinition
Anaerobic (AnO2) atmospheric generation IVDA pouch or unit intended to be used to reduce or deplete atmospheric oxygen (AnO2) to create an anaerobic environment suitable for the cultivation, processing, or testing of clinical laboratory specimens.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity00
Storage Environment Temperature00

Contacts#

Phone, Email table
PhoneEmail
+1-781-894-0800info@novabio.com

Regulatory Flags#

DUNS number
125006353
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
00816068020900Advanced Instruments Anoxomat III Anaerobic Culture System (100V - 120V)Anoxomat III (100V - 120V)Anoxomat III (100V - 120V)2020-09-21
00816068020917Advanced Instruments Ergonomic Culture Jar, SmallAJ9049AJ90492020-09-21
00816068020924Advanced Instruments Ergonomic Culture Jar, LargeAJ9050AJ90502020-09-21
00816068020948Advanced Instruments Standard Anoxomat Jar, MediumAJ9025AJ90252020-09-21
00816068020955Advanced Instruments Standard Anoxomat Jar, LargeAJ9028AJ90282020-09-21
00816068020023Advanced Instruments BR2 Disposable CuvettesB2A800B2A8002016-09-23
00816068020030Advanced Instruments BR2 Total Bilirubin Test Kit, Reagents, and CuvettesB2A101B2A1012016-09-23
00816068020047Advanced Instruments BR2 Total and Direct Test Kit, Reagents, and CuvettesB2A102B2A1022016-09-23
00816068020054Advanced Instruments BR2 Bilirubin Stat-AnalyzerBR2BR22016-09-23
00816068020078Advanced Instruments BR2 Sample DiluentB2A101D2016-09-23
00816068020085Advanced Instruments BR2 20 mg/dL Bilirubin Equivalent SolutionB2A101H2016-09-23
00816068020092Advanced Instruments BR2 5mg/dL Bilirubin Equivalent SolutionB2A101L2016-09-23
00816068020108Advanced Instruments BR2 Sodium NitriteB2A102N2016-09-23
00816068020115Advanced Instruments BR2 Sulfanilic AcidB2A102S2016-09-23
00816068020122Advanced Instruments BR2 Hydrochloric AcidB2A102Y2016-09-23
10816068020174Advanced Instruments Glocyte® Tips, 10 Pks of 96, 1-200uL Polypropylene8000978000972016-09-23
10816068020211Advanced Instruments GloCyte® Red Blood Cell Test Reagent Kit1110111110112016-09-23
00816068020535Advanced Instruments RBC Reagent Filtration Kit1110141110142021-05-21
00816068020856Advanced Instruments GloCyte RBC & TNC Verification & Linearity Kit1112801112802020-07-21
20816068020201Advanced Instruments GloCyte® Test Cartridge Kit - 8 Trays1110101110102016-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00382902604679BD BBL ™ GasPak™ 100 Vented LidBECTON, DICKINSON AND COMPANYKZJ2024-08-29
00673693228527EprediaRICHARD-ALLAN SCIENTIFIC COMPANYKZJ2024-08-09
05032384029648ANAEROBIC CATALYSTOXOID LIMITEDKZJ2022-12-12
05032384446148ANAEROGEN COMPACTOXOID LIMITEDKZJ2022-12-12
05032384003761YERSINIA SELECTIVE AGAR BASEOXOID LIMITEDKZJ2022-12-08
05032384028665ANAEROGEN 2.5L 10 PACKOXOID LIMITEDKZJ2022-12-08
05032384028672ANAEROGEN 3.5L 10 PACKOXOID LIMITEDKZJ2022-12-08
05032384028870CAMPYGEN (2.5 LITRES)OXOID LIMITEDKZJ2022-12-08
05032384028887CAMPYGEN (3.5 LITRES)OXOID LIMITEDKZJ2022-12-08
05032384029921ANAEROGEN COMPACT 10 PACKOXOID LIMITEDKZJ2022-12-08
05032384034611CAMPYGEN COMPACT (20 PER PACK)OXOID LIMITEDKZJ2022-12-08
05032384034932CO2GEN (10 SACHETS PER PACK)OXOID LIMITEDKZJ2022-12-08
05032384069132ANAEROGEN COMPACT 20 PACKOXOID LIMITEDKZJ2022-12-08
05032384123261CO2GEN COMPACT (20 PER PACK)OXOID LIMITEDKZJ2022-12-08
05032384161935ANAEROGEN W-ZIP COMPACTOXOID LIMITEDKZJ2022-12-08
05032384028405SINGLE DISC EJECTORSOXOID LIMITEDKZJ2022-12-07
05032384060122DESICCATED CARTRIDGE CONTAINEROXOID LIMITEDKZJ2022-12-07
00816068020900Advanced Instruments Anoxomat III Anaerobic Culture System (100V - 120V)Advanced Instruments, LLCKZJ2020-09-21
00816068020917Advanced Instruments Ergonomic Culture Jar, SmallAdvanced Instruments, LLCKZJ2020-09-21
00816068020924Advanced Instruments Ergonomic Culture Jar, LargeAdvanced Instruments, LLCKZJ2020-09-21
00816068020948Advanced Instruments Standard Anoxomat Jar, MediumAdvanced Instruments, LLCKZJ2020-09-21
00816068020955Advanced Instruments Standard Anoxomat Jar, LargeAdvanced Instruments, LLCKZJ2020-09-21
30382902600016BD GasPak™ EZ Anaerobe Container System Sachets with IndicatorBECTON, DICKINSON AND COMPANYKZJ2018-05-25
30382902606780BD GasPak™ EZ Anaerobe Container System SachetsBECTON, DICKINSON AND COMPANYKZJ2018-05-25
30382902606797BD GasPak™ EZ CO2 Container System SachetsBECTON, DICKINSON AND COMPANYKZJ2018-05-25
30382902606803BD GasPak™ EZ Campy Container System SachetsBECTON, DICKINSON AND COMPANYKZJ2018-05-25
30382902606834BD GasPak™ EZ Anaerobe Gas Generating Pouch System with IndicatorBECTON, DICKINSON AND COMPANYKZJ2018-05-25
30382902606841BD GasPak™ EZ CO2 Gas Generating Pouch SystemBECTON, DICKINSON AND COMPANYKZJ2018-05-25
30382902606858BD GasPak™ EZ Campy Gas Generating Pouch SystemBECTON, DICKINSON AND COMPANYKZJ2018-05-25
30382902612057BD CO2 Gas GeneratorsBECTON, DICKINSON AND COMPANYKZJ2018-05-25