FDA UDI
In Commercial Distribution
🇺🇸 United States
Cyclesure
DI: 10705037048564
·
Model: 14324-30
·
ADVANCED STERILIZATION PRODUCTS SERVICES INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
30
Basic Information
- Brand Name
- Cyclesure
- Primary DI
- 10705037048564
- Version / Model
- 14324-30
- Catalog Number
- 14324-30
- Company Name
- ADVANCED STERILIZATION PRODUCTS SERVICES INC.
- Labeler DUNS
- 947451626
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 30
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 5
- Public Version Date
- 2023-06-22
- Public Version Status
- Update
- Public Device Record Key
- 9e7fee27-c383-4687-88b6-802c822b2174
Device Description
Biological Indicator
Device Characteristics
- Single Use
- No
- 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
- No
- 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 |
|---|---|---|---|---|
| FRC | Indicator, biological sterilization process | General Hospital | 880.2800 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 13732 | Biological sterilization indicator | A sterilization indicator consisting of a standardized, viable population of microorganisms (e.g., bacterial spores known to be resistant to the mode of sterilization being monitored) that will display a change when exposed to an effective sterilization outcome indicating that sterilization parameters have been met. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10705037048564 | GS1 | ||||
| Unit of Use | 80705037048563 | GS1 |
Customer Contacts
- Phone
- +1(888)783-7723
- [email protected]
Premarket Submissions
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Do not store near any sterilizer, sources of ethylene oxide, hydrogen peroxide, acids, alkalis or volatile antimicrobials such as glutaraldehyde or formaldehyde,
- Type
- Special Storage Condition, Specify
- Special Conditions
- STERRAD® cassettes, or any other oxidizers.
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 25 Degrees Celsius