FDA UDI
In Commercial Distribution
🇺🇸 United States
BIOlogical12
DI: 10850065007813
·
Model: 3700
·
HF ACQUISITION CO. LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- BIOlogical12
- Primary DI
- 10850065007813
- Version / Model
- 3700
- Catalog Number
- 3700
- Company Name
- HF ACQUISITION CO. LLC
- Labeler DUNS
- 045657305
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-12-11
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- 85931f73-13e3-4ccb-9d2b-18b45b751e25
Device Description
Biological Indicator Mail-in Monitoring Test Strip
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
- Yes
- 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 | 10850065007813 | GS1 | ||||
| Package | 50850065007811 | GS1 | Master Case | 6 | In Commercial Distribution |
Customer Contacts
- Phone
- 800-331-1984
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Dispose of expired spore strips in a landfill or incinerator.
- Type
- Special Storage Condition, Specify
- Special Conditions
- Sterilize expired spore strips and culture media before disposal.
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store away from sterilizing units and other heat sources or chemical products.
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store in a cool, dry place.