Identity
- Trade Name
- Advanced Instruments Palladox Disposable Satchet FDA UDI
- Generic Name
- Anaerobic (AnO2) atmospheric generation IVD FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- AN3146 FDA UDI
- 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. FDA UDI
Identifiers
- Catalog Number
- AN3146 FDA UDI
- Primary DI / UDI-DI
- 00816068020962 FDA UDI
- FDA Product Code
- KZJ FDA UDI
- GMDN Term
- Anaerobic (AnO2) atmospheric generation IVD FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 866.2580 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Anaerobic (AnO2) atmospheric generation IVD
Advanced Instruments Palladox Disposable Satchet by Advanced Instruments, LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Anaerobic (AnO2) atmospheric generation IVD.
- Advanced Instruments Ergonomic Culture Jar, Small — Advanced Instruments, LLC · Class I
- Advanced Instruments Ergonomic Culture Jar, Large — Advanced Instruments, LLC · Class I
- Advanced Instruments Anoxomat III Anaerobic Culture System (100V - 120V) — Advanced Instruments, LLC · Class I
- Advanced Instruments Standard Anoxomat Jar, Large — Advanced Instruments, LLC · Class I
- Advanced Instruments Standard Anoxomat Jar, Medium — Advanced Instruments, LLC · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Advanced Instruments, LLC
Sources (1)
- FDA UDI 7cb49333-ff95-4003-8408-bde065a731b7 36 fields · synced Jun 8, 2026