Identity
- Trade Name
- Normnal Saline I.V. Flush Syringe FDA UDI
- Generic Name
- Vascular catheter flush syringe FDA UDI
- Device Name
- Medefil Normal Saline IV Flush Syringe, 1mL in 6mL syringe, does not contain natural latex rubber or preservatives, contents and its pathway are sterile. Single Use. FDA UDI
- Model / Reference
- 1mL in 6mL Syringe FDA UDI
- Description
- Medefil Normal Saline IV Flush Syringe, 1mL in 6mL syringe, does not contain natural latex rubber or preservatives, contents and its pathway are sterile. Single Use. FDA UDI
Identifiers
- Catalog Number
- MIS-1121 FDA UDI
- Primary DI / UDI-DI
- 30364253111212 FDA UDI
- 510(k) Number
- K091583 FDA UDI
- FDA Product Code
- NGT FDA UDI
- GMDN Term
- Vascular catheter flush syringe FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5200 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
Yes
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Vascular catheter flush syringe
Normnal Saline I.V. Flush Syringe by Medefil, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Vascular catheter flush syringe.
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Cleared under the same submission
K091583 also covers:
- McKesson — MCKESSON MEDICAL-SURGICAL INC.
- McKesson — MCKESSON MEDICAL-SURGICAL INC.
- McKesson — MCKESSON MEDICAL-SURGICAL INC.
- Normal Saline IV Flush Syriinge — MEDEFIL, INC.
- Normal Saline IV Flush Syringe — MEDEFIL, INC.
- Normal Saline IV Flush Syringe — MEDEFIL, INC.
- Normal Saline IV Flush Syringe — MEDEFIL, INC.
- Normal Saline IV Flush Syringe — MEDEFIL, INC.
- Normal Saline IV Flush Syringe — MEDEFIL, INC.
- Normal Saline IV Flush Syringe — MEDEFIL, INC.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Medefil, Inc.
Sources (1)
- FDA UDI f6484569-805f-41b2-9242-5958bc7d4f00 37 fields · synced May 30, 2026