FDA UDI
In Commercial Distribution
🇺🇸 United States
Rospital Productos Medicos
DI: 00812460028643
·
Model: VINLL
·
ATLAS MEDICAL PRODUCTS LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Rospital Productos Medicos
- Primary DI
- 00812460028643
- Version / Model
- VINLL
- Catalog Number
- VINLL
- Company Name
- ATLAS MEDICAL PRODUCTS LLC
- Labeler DUNS
- 013112308
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-10-18
- Public Version
- 1
- Public Version Date
- 2020-10-26
- Public Version Status
- New
- Public Device Record Key
- 58d929fe-f49e-40a7-bddc-0147ff4a65c7
Device Description
I.V. INFUSION SET, LUER LOCK, NO NEEDLE, STERILE. 1EA.
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
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- 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 |
|---|---|---|---|---|
| 17701 | Vascular port administration set | A collection of devices designed to conduct fluids from an intravenous (IV) fluid container to a patient's venous system via a previously implanted injection/infusion port. It typically includes a noncoring needle designed with a lateral hole (side-hole), tubing, connectors, chambers, clamps and may include an injection placement aid. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10812460028640 | GS1 | CASE | 400 | In Commercial Distribution | |
| Primary | 00812460028643 | GS1 |
Customer Contacts
- Phone
- 7864739436
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | I.V. INFUSION SET, LUER LOCK, NO NEEDLE, STERILE. 1EA. |