Identity
- Trade Name
- Guarded Luer Connector Female to Female FDA UDI
- Generic Name
- Luer/Luer linear connector, single-use FDA UDI
- Device Name
- Guarded Luer Connector Female to Female, Red, Sterile, Box of 50 individual blisters. FDA UDI
- Model / Reference
- 57-400 FDA UDI
- Description
- Guarded Luer Connector Female to Female, Red, Sterile, Box of 50 individual blisters. FDA UDI
Identifiers
- Catalog Number
- 57-400 FDA UDI
- Primary DI / UDI-DI
- B212574001 FDA UDI
- 510(k) Number
- K173577 FDA UDI
- FDA Product Code
- LHI FDA UDI
- GMDN Term
- Luer/Luer linear connector, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5440 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
Category: Luer/Luer linear connector, single-use
Guarded Luer Connector Female to Female by International Medical Industries Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K173577 also covers:
- Guarded Luer Connector Female Slip to Female Lock — INTERNATIONAL MEDICAL INDUSTRIES INC.
- Guarded Luer Connector Female Slip to Female Slip — INTERNATIONAL MEDICAL INDUSTRIES INC.
- Guarded Luer Connector Female to Female — INTERNATIONAL MEDICAL INDUSTRIES INC.
- Guarded Luer Connector Female to Male — INTERNATIONAL MEDICAL INDUSTRIES 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
- International Medical Industries Inc.
Sources (1)
- FDA UDI 37fa3a62-148f-4312-b774-0a5a53a4d118 35 fields · synced May 31, 2026