Identity
- Trade Name
- Celerity FDA UDI
- Generic Name
- Biological sterilization indicator FDA UDI
- Device Name
- The Celerity 5 HP Biological Indicator is used for routine monitoring of certain cycles of the V-PRO 1, 1 Plus, maX, maX2, 60, s2 Low Temperature Sterilization Systems, STERRAD 100S Sterilizer, STERRAD NX with or without ALLCLEAR, STERRAD 100NX with or without ALLCLEAR and when used in conjunction with the Celerity Incubator, the incubator provides a fluorescent result within 5 minutes. FDA UDI
- Model / Reference
- LCB052 FDA UDI
- Description
- The Celerity 5 HP Biological Indicator is used for routine monitoring of certain cycles of the V-PRO 1, 1 Plus, maX, maX2, 60, s2 Low Temperature Sterilization Systems, STERRAD 100S Sterilizer, STERRAD NX with or without ALLCLEAR, STERRAD 100NX with or without ALLCLEAR and when used in conjunction with the Celerity Incubator, the incubator provides a fluorescent result within 5 minutes. FDA UDI
Identifiers
- Catalog Number
- LCB052 FDA UDI
- Primary DI / UDI-DI
- 10724995215924 FDA UDI
- 510(k) Number
- K223717 FDA UDI
- FDA Product Code
- FRC FDA UDI
- GMDN Term
- Biological sterilization indicator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.2800 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
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Biological sterilization indicator
Celerity by Steris Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Biological sterilization indicator.
- SPORVIEW SELF-CONTAINED STEAM BI — Spsmedical Supply Corp. · Class II
- PASSPORT MAIL-IN SYSTEM — Spsmedical Supply Corp. · Class II
- Attest™ — 3M COMPANY · Class II
- BIOlogical12 — HF Acquisition Co. LLC · Class II
- Safco Tru-Verify™ Monitor — Safco Dental Supply · Class II
- Bionova® — TERRAGENE S.A. · Class II
- Bionova® — TERRAGENE S.A. · Class II
- Dual Spore Strips - Test — MESA LABORATORIES, INC. · Class II
Cleared under the same submission
K223717 also covers:
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 II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Steris Corporation
Sources (1)
- FDA UDI b6ce05cf-b3fd-4bc5-9595-34acb4bea574 36 fields · synced Jun 8, 2026