FDA UDI
In Commercial Distribution
🇺🇸 United States
CaviWipes1 XL
DI: 00615375004999
·
Model: 13-5150
·
METREX RESEARCH, LLC
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
65
Basic Information
- Brand Name
- CaviWipes1 XL
- Primary DI
- 00615375004999
- Version / Model
- 13-5150
- Company Name
- METREX RESEARCH, LLC
- Labeler DUNS
- 145963778
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 65
- Record Status
- Published
- Publish Date
- 2016-08-31
- Public Version
- 3
- Public Version Date
- 2019-05-23
- Public Version Status
- Update
- Public Device Record Key
- 8f4b8943-b69d-4ed8-beab-fd4fc04528a9
Device Description
1 Minute 1 Step Germicidal Wipes Fragrance Free Extra Large Canister of PreSaturated Towelettes
Device Characteristics
- Single Use
- Yes
- 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
- Yes
- 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 |
|---|---|---|---|---|
| LRJ | Disinfectant, medical devices | General Hospital | 880.6890 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58077 | Medical device cleaning/disinfection wipe | A moist, pre-treated fabric intended to be used to wipe the surface of medical devices and equipment to clean and/or destroy harmful microorganisms or inhibit their activity. The fabric is impregnated with a solution that may include a detergent(s) for cleaning surfaces and/or a disinfectant agent(s) or a precursor compound that forms a disinfectant agent when activated (e.g., by a separate solution). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Secondary | H97113515026 | HIBCC | ||||
| Primary | 00615375004999 | GS1 | ||||
| Unit of Use | 00615375007716 | GS1 |
Customer Contacts
- Phone
- +18008411428
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Net Contents 1 lb. 15 oz. 891g Towelette Dimension 9 x 12 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store in a cool place