FDA UDI
Not in Commercial Distribution
🇺🇸 United States
MRVLS
DI: 07290102590018
·
Model: NA
·
Elecam Medical Agricultural Cooperative Society Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- MRVLS
- Primary DI
- 07290102590018
- Version / Model
- NA
- Catalog Number
- 572808
- Company Name
- Elecam Medical Agricultural Cooperative Society Ltd.
- Labeler DUNS
- 532599255
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 6
- Public Version Date
- 2020-11-02
- Public Version Status
- Update
- Public Device Record Key
- ad23544e-2c78-4219-af8b-1ca28c514765
- Distribution End Date
- 2018-05-09
Device Description
MRVLS 4 WAY RAD Elcam Minimal Residual Volume Luer activated swabable stopcock (MRVLS)
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
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- Yes
- 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
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FMG | Stopcock, I.V. Set | General Hospital | 880.5440 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35375 | Stopcock | A general-purpose valve that is used to regulate the direction of a liquid or a gas flow. It is typically constructed of a durable material, e.g., plastic and/or metal, and may be used for a variety of general-purpose uses. For stopcocks used in intravenous (IV) lines for injection or removal of fluids see the appropriate GMDN code. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 17290102590015 | GS1 | dispenser | 45 | Not in Commercial Distribution | 2018-05-09 |
| Primary | 07290102590018 | GS1 | ||||
| Package | 27290102590012 | GS1 | Carton box | 6 | Not in Commercial Distribution | 2018-05-09 |
Customer Contacts
- Phone
- +97246988120
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K060231 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Pressure | 200 | KiloPascal |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 4 – 40 Degrees Celsius