Identity
- Trade Name
- Tamper Evident Cap FDA UDI
- Generic Name
- Syringe tip cap FDA UDI
- Device Name
- Warm Grey Tamper Evident Luer Lock Caps for IV Syringes. Sterile, Tray of 10, box of 1000. Provides Evidence of Access and maintains sterility. Includes OEM cosmetic logo FDA UDI
- Model / Reference
- 57-64 FDA UDI
- Description
- Warm Grey Tamper Evident Luer Lock Caps for IV Syringes. Sterile, Tray of 10, box of 1000. Provides Evidence of Access and maintains sterility. Includes OEM cosmetic logo FDA UDI
Identifiers
- Catalog Number
- 57-64 FDA UDI
- Primary DI / UDI-DI
- B21257641 FDA UDI
- 510(k) Number
- K861276 FDA UDI
- FDA Product Code
- FMF FDA UDI
- GMDN Term
- Syringe tip cap FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5860 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: Syringe tip cap
Tamper Evident Cap 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
K861276 also covers:
- Tamper Evident Cap — INTERNATIONAL MEDICAL INDUSTRIES INC.
- Tamper Evident Cap — INTERNATIONAL MEDICAL INDUSTRIES INC.
- Tamper Evident Cap — INTERNATIONAL MEDICAL INDUSTRIES INC.
- Tamper Evident Cap — INTERNATIONAL MEDICAL INDUSTRIES INC.
- Tamper Evident Cap — INTERNATIONAL MEDICAL INDUSTRIES INC.
- Tamper Evident Cap — INTERNATIONAL MEDICAL INDUSTRIES INC.
- Tamper Evident Cap — INTERNATIONAL MEDICAL INDUSTRIES INC.
- Tamper Evident Cap — INTERNATIONAL MEDICAL INDUSTRIES INC.
- Tamper Evident Cap — INTERNATIONAL MEDICAL INDUSTRIES INC.
- Tamper Evident Cap — INTERNATIONAL MEDICAL INDUSTRIES INC.
- Tamper Evident Cap — INTERNATIONAL MEDICAL INDUSTRIES INC.
- Tamper Evident Cap — 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- International Medical Industries Inc.
Sources (1)
- FDA UDI 775e1f4a-a158-44ec-a524-695dafd0c310 35 fields · synced Jun 8, 2026