FDA UDI
In Commercial Distribution
🇺🇸 United States
Actril Cold Sterilant
DI: 00677964000249
·
Model: 78337-000
·
MEDIVATORS INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Actril Cold Sterilant
- Primary DI
- 00677964000249
- Version / Model
- 78337-000
- Company Name
- MEDIVATORS INC.
- Labeler DUNS
- 068199363
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-02-26
- Public Version
- 5
- Public Version Date
- 2022-04-27
- Public Version Status
- Update
- Public Device Record Key
- 26353a3f-60e0-4ecb-b79e-d2451f709c90
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
- 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 |
|---|---|---|---|---|
| FKQ | System, Dialysate Delivery, Central Multiple Patient | Gastroenterology, Urology | 876.5820 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 40580 | Organic peroxy acid device sterilant, single-use | A substance in liquid or powder (reconstituted with water) form that includes an organic peroxy acid (e.g., peracetic acid, perpyruvic acid) as its primary agent intended to completely destroy or eliminate all harmful microorganisms on a medical device (e.g., surgical or dental instrument). The medical device is typically bathed by the substance for a specified period of time in order to achieve sterilization. After application, this device cannot be reused. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 30677964000240 | GS1 | Box | 4 | In Commercial Distribution | |
| Primary | 00677964000249 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K861730 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- High: 75 Degrees Fahrenheit