FDA UDI
In Commercial Distribution
🇺🇸 United States
Getinge Assured Smart-Read Biological Indicator, Getinge Assured AccuFast
DI: 00814434020776
·
Model: 504054100, 61301606636, 61301606637
·
STERITEC PRODUCT MFG. CO., INC.
Product Codes
1
GMDN Terms
1
Identifiers
5
Pkg Device Count
1
Basic Information
- Brand Name
- Getinge Assured Smart-Read Biological Indicator, Getinge Assured AccuFast
- Primary DI
- 00814434020776
- Version / Model
- 504054100, 61301606636, 61301606637
- Catalog Number
- 504054100, 61301606636, 61301606637
- Company Name
- STERITEC PRODUCT MFG. CO., INC.
- Labeler DUNS
- 622223196
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-23
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- 16c1b023-7675-4fca-a5e7-7526a870a5c1
Device Description
504054100 - Getinge Assured Smart-Read Biological Indicator - 100 ct. 61301606636 - Getinge Assured AccuFast Biological Indicator - 50 ct. 61301606637 - Getinge Assured AccuFast Biological Indicator - 100 ct.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- 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 | 40814434020774 | GS1 | Box | 100 | In Commercial Distribution | |
| Primary | 00814434020776 | GS1 | ||||
| Package | 30814434020777 | GS1 | Box | 50 | In Commercial Distribution | |
| Package | 20814434020770 | GS1 | Case | 4 | In Commercial Distribution | |
| Package | 10814434020773 | GS1 | Box | 100 | In Commercial Distribution |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store at room temperature