Identity
- Trade Name
- Tamper Evident Cap with Male Luer Lock FDA UDI
- Generic Name
- Basic intravenous administration set, noninvasive FDA UDI
- Device Name
- Sterile Red Tamper Evident Caps with Male Luer Lock Fitting. Provides evidence of access and maintains sterility. 1 Cap per sterile blister, 100 caps per shipper box FDA UDI
- Model / Reference
- 57-91 R FDA UDI
- Description
- Sterile Red Tamper Evident Caps with Male Luer Lock Fitting. Provides evidence of access and maintains sterility. 1 Cap per sterile blister, 100 caps per shipper box FDA UDI
Identifiers
- Catalog Number
- 57-91 R FDA UDI
- Primary DI / UDI-DI
- B2125791R1 FDA UDI
- 510(k) Number
- K182545 FDA UDI
- FDA Product Code
- FPA FDA UDI
- GMDN Term
- Basic intravenous administration set, noninvasive 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: Basic intravenous administration set, noninvasive
Tamper Evident Cap with Male Luer Lock 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
K182545 also covers:
- Tamper Evident Cap — INTERNATIONAL MEDICAL INDUSTRIES INC.
- Tamper Evident Cap for Luer Lock IV Syringes — INTERNATIONAL MEDICAL INDUSTRIES INC.
- Tamper Evident Cap for Luer Lock IV Syringes — INTERNATIONAL MEDICAL INDUSTRIES INC.
- Tamper Evident Cap for Luer Lock IV Syringes — INTERNATIONAL MEDICAL INDUSTRIES INC.
- Tamper Evident Cap for Luer Lock IV Syringes — INTERNATIONAL MEDICAL INDUSTRIES INC.
- Tamper Evident Cap for Luer Lock IV Syringes — 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 32ea9297-7f9e-4e3d-b5d0-9b9a0dd44287 35 fields · synced Jun 6, 2026