FDA UDI
In Commercial Distribution
🇺🇸 United States
MEDADV
DI: 00819667020180
·
Model: M811
·
MEDAS INC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- MEDADV
- Primary DI
- 00819667020180
- Version / Model
- M811
- Catalog Number
- M811
- Company Name
- MEDAS INC
- Labeler DUNS
- 080593067
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-04-09
- Public Version
- 2
- Public Version Date
- 2018-07-06
- Public Version Status
- New
- Public Device Record Key
- b001a686-d588-4224-bd2f-02504559ab13
Device Description
SCALP VEIN INFUSION SET TYPE BUTTERFLY 23G
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
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| FPA | Set, Administration, Intravascular | General Hospital | 880.5440 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 17825 | Scalp vein intravenous administration set | A collection of sterile devices designed to conduct fluids from an intravenous (IV) fluid container into a patient's scalp vein. It typically includes tubing, connectors, chambers, clamps, and specialized needles to access scalp veins. The device is normally intended for use on paediatric patients, especially infants. This is a single-use device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00819667020180 | GS1 |
Customer Contacts
- Phone
- +1(786)832-0459
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K083687 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- – 113 Degrees Fahrenheit