Identity
- Trade Name
- Heparin Lock Flush Syringe 100 Unit/mL FDA UDI
- Generic Name
- Vascular catheter/cannula flush solution, anticoagulant, non-antimicrobial FDA UDI
- Device Name
- Heparin Lock Flush Syringe 100 Unit/mL, 3 mL fill in 6 mL syringe, Does not contain natural rubber latex or preservatives, Contents and its pathway are sterile, Single Use FDA UDI
- Model / Reference
- 3mL in 6mL syringe FDA UDI
- Description
- Heparin Lock Flush Syringe 100 Unit/mL, 3 mL fill in 6 mL syringe, Does not contain natural rubber latex or preservatives, Contents and its pathway are sterile, Single Use FDA UDI
Identifiers
- Catalog Number
- MIH-3323 FDA UDI
- Primary DI / UDI-DI
- 30364253333232 FDA UDI
- 510(k) Number
- K092491 FDA UDI
- FDA Product Code
- NZW FDA UDI
- GMDN Term
- Vascular catheter/cannula flush solution, 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
Yes
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
Yes
FDA UDI
Category: Vascular catheter/cannula flush solution, anticoagulant, non-antimicrobial
Heparin Lock Flush Syringe 100 Unit/mL by Medefil, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Vascular catheter/cannula flush solution, anticoagulant, non-antimicrobial.
- Excelsior — MEDLINE INDUSTRIES, INC. · Class II
- PENDING — MEDLINE INDUSTRIES, INC. · Class II
- Excelsior — MEDLINE INDUSTRIES, INC. · Class II
- BD PosiFlush — BECTON DICKINSON AND COMPANY · Class II
- PENDING — MEDLINE INDUSTRIES, INC. · Class II
- Excelsior — MEDLINE INDUSTRIES, INC. · Class II
- Medline — MEDLINE INDUSTRIES, INC. · Class II
- PENDING — MEDLINE INDUSTRIES, INC. · Class II
Cleared under the same submission
K092491 also covers:
- McKesson — MCKESSON MEDICAL-SURGICAL INC.
- McKesson — MCKESSON MEDICAL-SURGICAL INC.
- McKesson — MCKESSON MEDICAL-SURGICAL INC.
- McKesson — MCKESSON MEDICAL-SURGICAL INC.
- Heparin Lock Flush Syringe 1 Units /mL — MEDEFIL, INC.
- Heparin Lock Flush Syringe 1 unit/mL — MEDEFIL, INC.
- Heparin Lock Flush Syringe 10 Units/mL — MEDEFIL, INC.
- Heparin Lock Flush Syringe 10 Units/mL — MEDEFIL, INC.
- Heparin Lock Flush Syringe 10 Units/mL — MEDEFIL, INC.
- Heparin Lock Flush Syringe 10 Units/mL — MEDEFIL, INC.
- Heparin Lock Flush Syringe 100 Unit /mL — MEDEFIL, INC.
- Heparin Lock Flush Syringe 100 Units/mL — 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 7486452f-5a1c-4233-ac9b-77965246473f 37 fields · synced May 30, 2026