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
NGT Saline, Vascular Access Flush

GMDN Terms

Code Name
64786 Vascular catheter/cannula flush solution, non-anticoagulant, non-antimicrobial

Identifiers

Type ID
Package 18904379807934
Primary 08904379807937
Package 58904379807932

Customer Contacts

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