FDA UDI
In Commercial Distribution
🇺🇸 United States
Peracidin™
DI: 00898021000181
·
Model: Quarts
·
Angelini Pharma Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Peracidin™
- Primary DI
- 00898021000181
- Version / Model
- Quarts
- Catalog Number
- 1632-12
- Company Name
- Angelini Pharma Inc.
- Labeler DUNS
- 078843940
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-08-29
- Public Version
- 4
- Public Version Date
- 2023-02-15
- Public Version Status
- Update
- Public Device Record Key
- 4318a842-2bfe-4431-bc10-45df2b2a6f5d
Device Description
PAA Dialyzer Disinfectant.
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
- 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 |
|---|---|---|---|---|
| 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 | 00898021000181 | GS1 | ||||
| Package | 00898021000211 | GS1 | Case | 12 | In Commercial Distribution |
Customer Contacts
- Phone
- 1-800-726-2308
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K962959 | 000 |
Storage Conditions
- 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
- Strong oxidizers, reacts violently with many other materials, particularly flammable and combustible organic materials.
- Type
- Special Storage Condition, Specify
- Special Conditions
- Stable under normal storage and handling conditions.Unstable when exposed to heat and contaminants.
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep away from flames and high temperatures. Avoid light and heat and keep in a closed but vented container to prevent evaporation (concentration) and contamination.