Identity
- Trade Name
- ENFit NeoSecure Tip Cap FDA UDI
- Generic Name
- Medicine bottle cap FDA UDI
- Device Name
- ENFit NeoSecure Tip Cap NonSterile Purp FDA UDI
- Model / Reference
- PNS-TCNC FDA UDI
- Description
- ENFit NeoSecure Tip Cap NonSterile Purp FDA UDI
Identifiers
- Catalog Number
- PNS-TCNC FDA UDI
- Primary DI / UDI-DI
- 00350770000381 FDA UDI
- 510(k) Number
- K152857 FDA UDI
- FDA Product Code
- PNR FDA UDI
- GMDN Term
- Medicine bottle 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: Medicine bottle cap
ENFit NeoSecure Tip Cap by Avanos Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Medicine bottle cap.
- Health Care Logistics, Inc® — Health Care Logistics · Class I
- NeoConnect Pharmacy Cap — NEOMED, INC. · Class I
- Safer Lock — Rxguardian Inc. · Class I
- NeoConnect Pharmacy Cap — NEOMED, INC. · Class I
- EXACTAMIX — Baxter Healthcare Corp · Class I
- Additive Cap — B. BRAUN MEDICAL INC. · Class II
- Health Care Logistics, Inc® — Health Care Logistics · Class I
- NeoMed Container with NeoConnect Transfer Lid, Purple — NEOMED, INC. · Class I
Cleared under the same submission
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
- Avanos Medical, Inc.
Sources (1)
- FDA UDI f8a2e87b-f89a-462f-9e03-0cf83d5027f8 36 fields · synced Jun 9, 2026