FDA UDI
In Commercial Distribution
🇺🇸 United States
RELI®
DI: 00386120013091
·
Model: PFSS-10ML-SP
·
MYCO MEDICAL SUPPLIES INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
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Basic Information
- Brand Name
- RELI®
- Primary DI
- 00386120013091
- Version / Model
- PFSS-10ML-SP
- Company Name
- MYCO MEDICAL SUPPLIES INC.
- Labeler DUNS
- 879187821
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-03-12
- Public Version
- 1
- Public Version Date
- 2024-03-20
- Public Version Status
- New
- Public Device Record Key
- f9bbbe91-d419-4561-8b54-34cb88d18e73
Device Description
RELI® Pre-Filled Saline Flush Syringe, 0.9% NaCl, 10ml LL, STERILE FLUID PATH Peel Pouch, 30EA/BX, 6BX/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 |
|---|---|---|---|---|
| NGT | Saline, Vascular Access Flush | General Hospital | 880.5200 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64786 | Vascular catheter/cannula flush solution, non-anticoagulant, non-antimicrobial | A solution (e.g., saline, sterile water) intended to flush the lumen of an in situ intravenous access device (IVAD), typically a peripheral intravenous cannula or central venous catheter, to maintain patency; it does not include an anticoagulant or antimicrobial agent. Also known as lock solution, the device is available in a small container (e.g., bottle) or prefilled syringe. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10386120013098 | GS1 | Inner Carton | 30 | In Commercial Distribution | |
| Primary | 00386120013091 | GS1 | ||||
| Package | 20386120013095 | GS1 | Case | 6 | In Commercial Distribution |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K220060 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Total Volume | 10 | Milliliter |