FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Celerity
DI: 00724995154257
·
Model: LCB046
·
STERIS CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Celerity
- Primary DI
- 00724995154257
- Version / Model
- LCB046
- Catalog Number
- LCB046
- Company Name
- STERIS CORPORATION
- Labeler DUNS
- 868205779
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-11-17
- Public Version
- 8
- Public Version Date
- 2022-04-25
- Public Version Status
- Update
- Public Device Record Key
- 12b705e0-0fde-457b-a319-8f588324f1e0
- Distribution End Date
- 2022-04-25
Device Description
The Celerity HP Incubator was designed exclusively to incubate and read activated Celerity 20 HP Biological Indicators.
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
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- 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 |
|---|---|---|---|---|
| 46944 | Test tube heater | An electrically-powered device used in the laboratory to hold and maintain at specific temperatures test tubes containing a fluid specimen (e.g., cell samples). The device typically contains several slots to hold test tubes upright, and its heating element is controlled electronically to reliably maintain a physiological temperature. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00724995154257 | GS1 |
Customer Contacts
- Phone
- +1(800)548-4873
- [email protected]