FDA UDI
In Commercial Distribution
🇺🇸 United States
Medline
DI: 10080196139132
·
Model: MDS88OPASTP
·
MEDLINE INDUSTRIES, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
50
Basic Information
- Brand Name
- Medline
- Primary DI
- 10080196139132
- Version / Model
- MDS88OPASTP
- Catalog Number
- MDS88OPASTP
- Company Name
- MEDLINE INDUSTRIES, INC.
- Labeler DUNS
- 025460908
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 50
- Record Status
- Published
- Publish Date
- 2023-01-27
- Public Version
- 1
- Public Version Date
- 2023-02-06
- Public Version Status
- New
- Public Device Record Key
- 65c94737-ad88-407b-9c3b-604b884f5c81
Device Description
OPA DISINFECTANT TEST STRIP
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
- 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 |
|---|---|---|---|---|
| 46945 | Ortho-phthalaldehyde (OPA) device disinfectant 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 ortho-phthalaldehyde (OPA) in a device disinfectant solution after preparation to ensure disinfectant properties. It is used to prevent diluting the disinfectant 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 | 40080196139133 | GS1 | CASE | 2 | In Commercial Distribution | |
| Primary | 10080196139132 | GS1 | ||||
| Unit of Use | 20080196139139 | GS1 |
Customer Contacts
- Phone
- +1(800)633-5463
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 30 Degrees Celsius