FDA UDI
In Commercial Distribution
🇺🇸 United States
RELI®
DI: 00386120013107
·
Model: GSBCS21G-12
·
MYCO MEDICAL SUPPLIES INC.
Product Codes
2
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- RELI®
- Primary DI
- 00386120013107
- Version / Model
- GSBCS21G-12
- Company Name
- MYCO MEDICAL SUPPLIES INC.
- Labeler DUNS
- 879187821
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-02-22
- Public Version
- 1
- Public Version Date
- 2024-03-01
- Public Version Status
- New
- Public Device Record Key
- d6bab985-198e-4623-8716-8cae26b64b4d
Device Description
Reli Gem Safety Blood Collection Set 21G x 3/4", 12" tubing with EZ Flash Technology
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 |
|---|---|---|---|---|
| FPA | Set, Administration, Intravascular | General Hospital | 880.5440 | 2 |
| FMI | Needle, Hypodermic, Single Lumen | General Hospital | 880.5570 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58497 | Blood collection set, invasive | A collection of devices intended to be used by a healthcare professional, in combination with evacuated blood collection tubes, for the routine collection of multiple blood specimens from a patient, via one venipuncture, for clinical analyses. It consists of a blood collection needle or venous butterfly/scalp vein needle and additional devices that may include tubing, male/female Luer-lock connectors, clamps, and a blood collection tube holder. Blood access is directly through the vein with the 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 | 10386120013104 | GS1 | Inner Carton | 100 | In Commercial Distribution | |
| Primary | 00386120013107 | GS1 | ||||
| Package | 20386120013101 | GS1 | Case | 9 | In Commercial Distribution |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K170276 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Needle Gauge | 21 | Gauge | |
| Device Size Text, specify | 12" Tubing |