FDA UDI
In Commercial Distribution
🇺🇸 United States
trophon Chemical Indicator
DI: 09350855000542
·
Model: N05003
·
NANOSONICS LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
240
Basic Information
- Brand Name
- trophon Chemical Indicator
- Primary DI
- 09350855000542
- Version / Model
- N05003
- Catalog Number
- N05003
- Company Name
- NANOSONICS LIMITED
- Labeler DUNS
- 741021943
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 240
- Record Status
- Published
- Publish Date
- 2022-05-12
- Public Version
- 1
- Public Version Date
- 2022-05-20
- Public Version Status
- New
- Public Device Record Key
- e2450a9f-3685-409b-9e71-eacd6fff4c72
Device Description
Chemical Indicator
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| JOJ | Indicator, Physical/Chemical Sterilization Process | General Hospital | 880.2800 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35362 | Chemical/physical sterilization process indicator | A sterilization indicator designed to be placed within a sterilizing chamber, and to respond with a characteristic chemical and/or physical change to one or more of the physical conditions within the chamber, to validate the sterilization process. It may be presented in one of a variety of forms (e.g., tape, test pack, tag). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 09350855000542 | GS1 | ||||
| Unit of Use | 09350855000399 | GS1 |
Customer Contacts
- Phone
- 844-876-7466
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K103126 | 000 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- 15C – 30C (59F – 86F)