Identity
- Trade Name
- Praxiject™ 0.9% NaCl FDA UDI
- Generic Name
- Vascular catheter/cannula flush solution, non-anticoagulant, non-antimicrobial FDA UDI
- Device Name
- 10 mL of 0.9% Sodium Chloride Injection USP in a 10 mL syringe FDA UDI
- Model / Reference
- 3705-1US FDA UDI
- Description
- 10 mL of 0.9% Sodium Chloride Injection USP in a 10 mL syringe FDA UDI
Identifiers
- Catalog Number
- 3705-1US FDA UDI
- Primary DI / UDI-DI
- 10682686004540 FDA UDI
- 510(k) Number
- K192414 FDA UDI
- FDA Product Code
- NGT FDA UDI
- GMDN Term
- Vascular catheter/cannula flush solution, non-anticoagulant, non-antimicrobial 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
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Total Volume — 10 Milliliter FDA UDI
Category: Vascular catheter/cannula flush solution, non-anticoagulant, non-antimicrobial
Praxiject™ 0.9% NaCl by MedXL — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Vascular catheter/cannula flush solution, non-anticoagulant, non-antimicrobial.
- BAL Flush Spritze 10ml DS — Jiaxing Tianhe Pharmaceutical Co., Ltd. · Class IIa
- Pre-fillefd flush syringe(B001-MY) — Jiangsu Embrace Science&Technology Development Co., Ltd. · Class IIa
- Burg Pharma — Jiangsu Caina Medical Co.,Ltd. · Class IIa
- BAL Flush Spritze 5ml SS — Jiaxing Tianhe Pharmaceutical Co., Ltd. · Class IIa
- Pre-Filled Saline Flush Syringe, Sterile, 5mL — Dynarex Corp. · Class II
- Halyard — OWENS & MINOR DISTRIBUTION, INC. · Class II
- EASY FLUSH — SPM MEDICARE PVT, LTD. · Class IIb
- Prefilled Syringe with 0.9% Saline Solution — Poly Medicure Limited · Class IIb
Cleared under the same submission
K192414 also covers:
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- MedXL
Sources (1)
- FDA UDI 419f2ac8-2e92-4988-b920-ffcd1d7f4932 38 fields · synced May 31, 2026