Identity
- Trade Name
- ProCure FDA UDI
- Generic Name
- ENFit oral/enteral syringe, single-use FDA UDI
- Device Name
- Enteral Piston Syringe, FlatTop, 60cc, w/ IV Pole Bag 30ea/cs FDA UDI
- Model / Reference
- PC700 FDA UDI
- Description
- Enteral Piston Syringe, FlatTop, 60cc, w/ IV Pole Bag 30ea/cs FDA UDI
Identifiers
- Catalog Number
- PC700 FDA UDI
- Primary DI / UDI-DI
- 10840330701812 FDA UDI
- FDA Product Code
- KYZ FDA UDI
- GMDN Term
- ENFit oral/enteral syringe, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 880.6960 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: ENFit oral/enteral syringe, single-use
ProCure by Twin Med, LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as ENFit oral/enteral syringe, single-use.
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- Ameritus Oral Syringe — KENTEC MEDICAL, INC. · Class I
- VYGON — Vygon Corp. · Class II
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 I | Pending data |
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Manufacturer
- Manufacturer
- Twin Med, LLC
Sources (1)
- FDA UDI 4b52bef1-8168-48a4-b913-61706735b353 35 fields · synced Jun 1, 2026