Identity
- Trade Name
- Gastrostomy Tube with ENFit connector FDA UDI
- Generic Name
- Gastrostomy tube FDA UDI
- Device Name
- Gastrostomy Tube with ENFit connector, 16FR FDA UDI
- Model / Reference
- ENFIT70316 FDA UDI
- Description
- Gastrostomy Tube with ENFit connector, 16FR FDA UDI
Identifiers
- Catalog Number
- 70-0064-116 FDA UDI
- Primary DI / UDI-DI
- 10888277411043 FDA UDI
- 510(k) Number
- K142075 FDA UDI
- FDA Product Code
- PIF FDA UDI
- GMDN Term
- Gastrostomy tube 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
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
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
MR Conditional FDA UDI
Category: Gastrostomy tube
Gastrostomy Tube with ENFit connector by Medline Industries, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Gastrostomy tube.
- Balloon G-Tube — Applied Medical Technology, Inc. · Class II
- Entuit Gastrostomy BR Balloon Retention Feeding Tube with ENFit Connection — Xeridiem Medical Devices · Class II
- AMT Balloon G-Tube — Applied Medical Technology, Inc. · Class II
- AVANOS — Avanos Medical, Inc. · Class II
- Low-Profile Gastrostomy Replacement Tube (G. Button) Kit — Sky Medical a.s. · Class IIb
- Kangaroo — Cardinalhealth · Class II
- Gastrostomy Tube — Hangzhou Fushan Medical Appliances Co., Ltd. · Class IIa
- EndoVive™ Low Profile Replacement Button — Boston Scientific · Class II
Cleared under the same submission
K142075 also covers:
- Gastrostomy Tube with ENFit connector — MEDLINE INDUSTRIES, INC.
- Gastrostomy Tube with ENFit connector — MEDLINE INDUSTRIES, INC.
- Gastrostomy Tube with ENFit connector — MEDLINE INDUSTRIES, INC.
- Gastrostomy Tube with ENFit connector — MEDLINE INDUSTRIES, INC.
- Gastrostomy Tube with ENFit connector — MEDLINE INDUSTRIES, INC.
- EndoVive Gastrostomy Tube, Right Angle, with ENFit Connector — Xeridiem Medical Devices
- EndoVive Gastrostomy Tube, Right Angle, with ENFit Connector — Xeridiem Medical Devices
- EndoVive Gastrostomy Tube, Right Angle, with ENFit Connector — Xeridiem Medical Devices
- EndoVive Gastrostomy Tube, Right Angle, with ENFit Connector — Xeridiem Medical Devices
- EndoVive Gastrostomy Tube, Right Angle, with ENFit Connector — Xeridiem Medical Devices
- EndoVive Gastrostomy Tube, Right Angle, with ENFit Connector — Xeridiem Medical Devices
- EndoVive Gastrostomy Tube, Right Angle, with ENFit Connector — Xeridiem Medical Devices
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
- Medline Industries, Inc.
Sources (1)
- FDA UDI dac9d788-515e-4e9e-8a28-5f900c7421d2 36 fields · synced May 30, 2026