Identity
- Trade Name
- Tamper Evident Cap for use with ENFit FDA UDI
- Generic Name
- ENFit-formatted protective cap FDA UDI
- Device Name
- Tamper Evident Cap for Use With ENFit® Syringes (ETEC) FDA UDI
- Model / Reference
- 57-220-100 RFID FDA UDI
- Description
- Tamper Evident Cap for Use With ENFit® Syringes (ETEC) FDA UDI
Identifiers
- Primary DI / UDI-DI
- B21257220100RFID1 FDA UDI
- 510(k) Number
- K170672 FDA UDI
- FDA Product Code
- PNR FDA UDI
- GMDN Term
- ENFit-formatted protective cap FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.5980 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
Yes
FDA UDI
Category: ENFit-formatted protective cap
Tamper Evident Cap for use with ENFit by International Medical Industries Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as ENFit-formatted protective cap.
- RxCrush — Resolve Designs LLC · Class I
- Enteral Feeding — Medela LLC · Class II
- Enteral — GBUK ENTERAL LIMITED · Class I
- Enteral — GBUK ENTERAL LIMITED · Class I
- Enteral — GBUK ENTERAL LIMITED · Class II
- Enteral — GBUK ENTERAL LIMITED · Class II
- Enteral — GBUK ENTERAL LIMITED · Class I
- Tamper Evident Cap with ENFit — INTERNATIONAL MEDICAL INDUSTRIES INC. · Class II
Cleared under the same submission
K170672 also covers:
- NeoConnect Tamper Evident Cap Enfit Syringe Compatible — INTERNATIONAL MEDICAL INDUSTRIES INC.
- Tamper Evident Cap for ENFit Syringe — INTERNATIONAL MEDICAL INDUSTRIES INC.
- Tamper Evident Cap for use with ENFit Syringes — INTERNATIONAL MEDICAL INDUSTRIES INC.
- Tamper Evident Cap for use with ENFit Syringes — INTERNATIONAL MEDICAL INDUSTRIES INC.
- Tamper Evident Cap with ENFit — 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 0bb916ae-a9e2-44c8-8266-1f89c96f5fba 34 fields · synced May 30, 2026