Identity
- Trade Name
- AMT Bridle Pro™ FDA UDI
- Generic Name
- Nasogastric tube holder, noninvasive FDA UDI
- Device Name
- 16F AMT Bridle Pro Nasal Tube Retaining System (Pouched) FDA UDI
- Model / Reference
- E4-4216 FDA UDI
- Description
- 16F AMT Bridle Pro Nasal Tube Retaining System (Pouched) FDA UDI
Identifiers
- Catalog Number
- E4-4216, 4-4216 FDA UDI
- Primary DI / UDI-DI
- 00842071118105 FDA UDI
- FDA Product Code
- KNT FDA UDI
- GMDN Term
- Nasogastric tube holder, noninvasive 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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Safe FDA UDI
Dimensions & Sizes
- Size
- Catheter Gauge — 16 French FDA UDI
Category: Nasogastric tube holder, noninvasive
AMT Bridle Pro™ by Applied Medical Technology, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Nasogastric tube holder, noninvasive.
- Dale Nasogastric Tube Holder — Dale Medical Products, Inc. · Class I
- Dale Nasogastric Tube Holder — Dale Medical Products, Inc. · Class I
- Grip-Lok — TIDI PRODUCTS, LLC · Class II
- 3M™ — 3M COMPANY · Class I
- NG Strip™ — Derma Sciences Canada, Inc · Class I
- NG SECURE — M. C. JOHNSON CO., INC. · Class I
- Catheter Stabilization Device — C. R. Bard, Inc. · Class I
- Halyard — OWENS & MINOR DISTRIBUTION, INC. · Class I
Cleared under the same submission
K030784 also covers:
- AMT Bridle Pro® — Applied Medical Technology, Inc.
- AMT Bridle Pro® — Applied Medical Technology, Inc.
- AMT Bridle Pro® — Applied Medical Technology, Inc.
- AMT Bridle Pro™ — Applied Medical Technology, Inc.
- AMT Bridle Pro™ — Applied Medical Technology, Inc.
- AMT Bridle Pro™ — Applied Medical Technology, Inc.
- AMT Bridle Pro™ — Applied Medical Technology, Inc.
- AMT Bridle Pro™ — Applied Medical Technology, Inc.
- AMT Bridle Pro™ Spare Clip — Applied Medical Technology, Inc.
- AMT Bridle Pro™ Spare Clip — Applied Medical Technology, Inc.
- AMT Bridle Pro™ Spare Clip — Applied Medical Technology, Inc.
- AMT Bridle Pro™ Spare Clip — Applied Medical Technology, Inc.
K142971 also covers:
- AMT Bridle Pro® — Applied Medical Technology, Inc.
- AMT Bridle Pro® — Applied Medical Technology, Inc.
- AMT Bridle Pro® — Applied Medical Technology, Inc.
- AMT Bridle Pro™ — Applied Medical Technology, Inc.
- AMT Bridle Pro™ — Applied Medical Technology, Inc.
- AMT Bridle Pro™ — Applied Medical Technology, Inc.
- AMT Bridle Pro™ — Applied Medical Technology, Inc.
- AMT Bridle Pro™ — Applied Medical Technology, Inc.
- AMT Bridle Pro™ Spare Clip — Applied Medical Technology, Inc.
- AMT Bridle Pro™ Spare Clip — Applied Medical Technology, Inc.
- AMT Bridle Pro™ Spare Clip — Applied Medical Technology, Inc.
- AMT Bridle Pro™ Spare Clip — Applied Medical Technology, 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
- Applied Medical Technology, Inc.
Sources (1)
- FDA UDI 5757adde-06f0-4ed2-8269-56998a514452 37 fields · synced Jun 9, 2026