FDA UDI
In Commercial Distribution
🇺🇸 United States
Rapicide Glutaraldehyde Indicator Test Strips
DI: 10677964063623
·
Model: ML02-0120
·
MEDIVATORS INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
60
Basic Information
- Brand Name
- Rapicide Glutaraldehyde Indicator Test Strips
- Primary DI
- 10677964063623
- Version / Model
- ML02-0120
- Company Name
- MEDIVATORS INC.
- Labeler DUNS
- 068199363
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 60
- Record Status
- Published
- Publish Date
- 2018-03-07
- Public Version
- 4
- Public Version Date
- 2022-04-27
- Public Version Status
- Update
- Public Device Record Key
- a6c3e65e-f371-40b8-bce5-51564161aafa
Device Characteristics
- Single Use
- No
- 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
- 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 |
|---|---|---|---|---|
| JOJ | Indicator, Physical/Chemical Sterilization Process | General Hospital | 880.2800 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47056 | Glutaraldehyde device disinfectant/sterilant test strip | A sliver of absorbent material impregnated with chemical indicators and dyes intended to be used to rapidly indicate, through colour change, the concentration of glutaraldehyde in a device disinfectant and/or sterilant solution after preparation to ensure disinfectant/sterilant properties. It is used to prevent diluting the disinfectant/sterilant to a concentration that is lower than the manufacturer's recommended minimum effective concentration (MEC). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 30677964063627 | GS1 | Box | 2 | In Commercial Distribution | |
| Primary | 10677964063623 | GS1 | ||||
| Unit of Use | 00677964063626 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K080750 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 43 – 86 Degrees Fahrenheit