Identity
- Trade Name
- Tamper Evident Cap for ENFit Syringe FDA UDI
- Generic Name
- Syringe tip cap FDA UDI
- Device Name
- Tamper evident cap for use with ENFit syringes; red; Baxter; non-sterile; bag of 100; package of 1000; provides positive closure and tamper evidence. FDA UDI
- Model / Reference
- 53310 FDA UDI
- Description
- Tamper evident cap for use with ENFit syringes; red; Baxter; non-sterile; bag of 100; package of 1000; provides positive closure and tamper evidence. FDA UDI
Identifiers
- Catalog Number
- 53310 FDA UDI
- Primary DI / UDI-DI
- B212H938533101 FDA UDI
- 510(k) Number
- K170672 FDA UDI
- FDA Product Code
- PNR FDA UDI
- GMDN Term
- Syringe tip 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
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Syringe tip cap
Tamper Evident Cap for ENFit Syringe by International Medical Industries Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Syringe tip cap.
- Chromaclone PVS Mixing Tip — ULTRADENT PRODUCTS, INC. · Class I
- Endo-Eze Tip — ULTRADENT PRODUCTS, INC. · Class I
- PATTERSON — PATTERSON DENTAL SUPPLY, INC. · Class I
- Micro Applicator — ULTRADENT PRODUCTS, INC. · Class I
- Monoject — Cardinalhealth · Class I
- PATTERSON — PATTERSON DENTAL SUPPLY, INC. · Class I
- NeoConnect Syringe Tip Cap — NEOMED, INC. · Class II
- Chromaclone PVS Mixing Tip — ULTRADENT PRODUCTS, INC. · Class I
Cleared under the same submission
K170672 also covers:
- NeoConnect Tamper Evident Cap Enfit Syringe Compatible — INTERNATIONAL MEDICAL INDUSTRIES INC.
- Tamper Evident Cap for use with ENFit — 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- International Medical Industries Inc.
Sources (1)
- FDA UDI 7ecb1ed8-64e1-4c8f-88cf-8d464cda12c6 35 fields · synced Jun 1, 2026