FDA UDI
In Commercial Distribution
🇺🇸 United States
Cyclesure
DI: 10705037016211
·
Model: 14324
·
ADVANCED STERILIZATION PRODUCTS SERVICES INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
60
Basic Information
- Brand Name
- Cyclesure
- Primary DI
- 10705037016211
- Version / Model
- 14324
- Catalog Number
- 14324
- Company Name
- ADVANCED STERILIZATION PRODUCTS SERVICES INC.
- Labeler DUNS
- 947451626
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 60
- 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
- 3ff38281-28ae-43ad-a5e2-c6f3fcd8d295
Device Description
Biological 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 |
|---|---|---|---|---|
| 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 |
|---|---|---|---|---|---|---|
| Package | 20705037016218 | GS1 | Case | 4 | In Commercial Distribution | |
| Primary | 10705037016211 | GS1 | ||||
| Unit of Use | 80705037016210 | 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,STERRAD® cassettes,
- Type
- Special Storage Condition, Specify
- Special Conditions
- or any other oxidizers.Do not spill solvents such as IPA or Acetone on the tape as the solvents may dissolve the chemical indicator.
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 25 Degrees Celsius