FDA UDI
In Commercial Distribution
🇺🇸 United States
RELI®
DI: 00386120012919
·
Model: SHN21G101-S5ML
·
MYCO MEDICAL SUPPLIES INC.
Product Codes
3
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- RELI®
- Primary DI
- 00386120012919
- Version / Model
- SHN21G101-S5ML
- Company Name
- MYCO MEDICAL SUPPLIES INC.
- Labeler DUNS
- 879187821
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-03-14
- Public Version
- 1
- Public Version Date
- 2023-03-22
- Public Version Status
- New
- Public Device Record Key
- fe8745b0-3781-48d6-9082-1d5194ac6476
Device Description
Reli® Safety Hypodermic Needle with Syringe, 5ml, 21G x 1", 100ea/bx, 8bx/cs
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
- 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 |
|---|---|---|---|---|
| FMI | Needle, Hypodermic, Single Lumen | General Hospital | 880.5570 | 2 |
| MEG | Syringe, Antistick | General Hospital | 880.5860 | 2 |
| FMF | Syringe, Piston | General Hospital | 880.5860 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 59230 | Hypodermic needle, single-use | A non-dedicated, sharp bevel-edged, hollow tubular device intended to be inserted beneath the skin of a patient while connected to a noninvasive device (e.g., syringe, secondary medication set) to administer and/or withdraw (aspirate) fluids/drugs; it may also be used for fluid/drug preparation. Some types are designed with a shielding mechanism (e.g., safety cap) for protection from sharp injuries. It is not specifically designed for blood collection or artery puncture, and does not have wings for fixation/placement (i.e., not a blood collection, intra-arterial, or venous butterfly needle). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10386120012916 | GS1 | Inner Carton | 100 | In Commercial Distribution | |
| Primary | 00386120012919 | GS1 | ||||
| Package | 30386120012910 | GS1 | Case | 8 | In Commercial Distribution |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Total Volume | 5 | Milliliter | |
| Needle Gauge | 21 | Gauge | |
| Length | 1 | Inch |