FDA UDI
In Commercial Distribution
🇺🇸 United States
Easy Flush
DI: 08904379807937
·
Model: 5 ml (Sterile Fluid Path)
·
SPM MEDICARE PRIVATE LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Easy Flush
- Primary DI
- 08904379807937
- Version / Model
- 5 ml (Sterile Fluid Path)
- Catalog Number
- 1BO7R5S
- Company Name
- SPM MEDICARE PRIVATE LIMITED
- Labeler DUNS
- 873722580
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-03-07
- Public Version
- 1
- Public Version Date
- 2026-03-16
- Public Version Status
- New
- Public Device Record Key
- 297e972d-1093-4a64-818a-f4a71301d846
Device Description
SPM’s Easy Flush syringe is a ready-to-use flush syringe intended to clear intravenous lines. Easy Flush is a polypropylene prefilled syringe that contains sterile, non-pyrogenic 0.9% w/v sodium chloride (saline) solution. SPM’s EasyFlush syringe is a sterile, single-use, non-toxic and non-pyrogenic Medical Device. It is sterilized by Gamma irradiation. A EasyFlush syringe is used to help prevent vascular access systems from becoming blocked and to help remove any medication that may be left at the catheter site. The syringe is designed for manual use.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- Yes
- Not Made with NRL
- No
- 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
- 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 | 18904379807934 | GS1 | Inner Carton | 50 | In Commercial Distribution | |
| Primary | 08904379807937 | GS1 | ||||
| Package | 58904379807932 | GS1 | Outer Carton | 400 | In Commercial Distribution |
Customer Contacts
- Phone
- +918407070718
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K231724 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Total Volume | 5 | Milliliter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 10 – 40 Degrees Celsius