FDA UDI
In Commercial Distribution
🇺🇸 United States
RELI®
DI: 00386120010878
·
Model: UUBPC15
·
MYCO MEDICAL SUPPLIES INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- RELI®
- Primary DI
- 00386120010878
- Version / Model
- UUBPC15
- Catalog Number
- UUBPC15
- Company Name
- MYCO MEDICAL SUPPLIES INC.
- Labeler DUNS
- 879187821
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-11-18
- Public Version
- 1
- Public Version Date
- 2020-11-26
- Public Version Status
- New
- Public Device Record Key
- fb2a8f6d-b1fa-45fa-a20d-d1e14732f205
Device Description
RELI® Blunt Plastic Cannula, 15G
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
- 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
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GAA | Needle, Aspiration And Injection, Disposable | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 16628 | Medication transfer needle, vented | A slender, rigid, sharp or blunt tube intended to be attached to a syringe and typically used in the pharmacy to aspirate and transfer fluid medication from a vial/ampule to another container for medication preparation or other purposes. It includes a thin channel cut along its outer surface forming an integral vent that relieves any back pressure in the vial during the transfer of medication [e.g., transfer of drugs from vials to intravenous (IV) bags, filling vials] to help minimize risk of contamination; it does not include a filter. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10386120010875 | GS1 | Inner Carton | 100 | In Commercial Distribution | |
| Primary | 00386120010878 | GS1 | ||||
| Package | 20386120010872 | GS1 | Case | 10 | In Commercial Distribution |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Needle Gauge | 15 | Gauge |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 4 – 36 Degrees Celsius