FDA UDI
In Commercial Distribution
🇺🇸 United States
Peracidin RO Disinfectant
DI: 00898021000303
·
Model: Gallon
·
Angelini Pharma Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Peracidin RO Disinfectant
- Primary DI
- 00898021000303
- Version / Model
- Gallon
- Catalog Number
- 1633G
- Company Name
- Angelini Pharma Inc.
- Labeler DUNS
- 078843940
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-08-04
- Public Version
- 3
- Public Version Date
- 2023-02-15
- Public Version Status
- Update
- Public Device Record Key
- 2e443b57-c849-4f66-9695-ab9bd4099a0a
Device Description
Peracidin® RO Disinfectant is intended for the disinfection of water purification systems for hemodialysis.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- 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
- Yes
- 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 |
|---|---|---|---|---|
| MED | Sterilant, Medical Devices | General Hospital | 880.6885 | 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 |
|---|---|---|---|---|---|---|
| Primary | 00898021000303 | GS1 |
Customer Contacts
- Phone
- 800.726-2308
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Strong oxidizers, reacts violently with many other materials, particularly flammable and combustible organic materials.
- Type
- Special Storage Condition, Specify
- Special Conditions
- Avoid contamination from any source, including metals, dust, organic matter, etc. Such contamination may cause rapid decomposition, generation of large quantities of oxygen gas and high pressures.
- Type
- Special Storage Condition, Specify
- Special Conditions
- Explosive pressure rupture of the container can occur if not properly vented.
- Type
- Special Storage Condition, Specify
- Special Conditions
- Stable under normal storage and handling conditions. Unstable when exposed to heat and contaminants.