FDA UDI
In Commercial Distribution
🇺🇸 United States
AMT Bridle™ Pro
DI: 00842071115890
·
Model: E4-421618
·
APPLIED MEDICAL TECHNOLOGY, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- AMT Bridle™ Pro
- Primary DI
- 00842071115890
- Version / Model
- E4-421618
- Catalog Number
- E4-421618, 4-421618
- Company Name
- APPLIED MEDICAL TECHNOLOGY, INC.
- Labeler DUNS
- 038101861
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-12-30
- Public Version
- 5
- Public Version Date
- 2019-07-22
- Public Version Status
- Update
- Public Device Record Key
- 8606a6f6-1a84-48ba-b321-45d09b333409
Device Description
16 - 18 FR AMT Bridle Pro Nasal Tube Retaining System (Pouched)
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- MR Safe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KNT | Tubes, Gastrointestinal (And Accessories) | Gastroenterology, Urology | 876.5980 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36053 | Nasogastric tube holder, noninvasive | A small, noninvasive device intended to be used to secure a nasogastric tube to prevent displacement or removal of the tube from the patient. It is typically designed as an adhesive plaster with wings that are attached to the face (e.g., across the bridge of the nose, on the cheeks). It may have a lock-ring or non-adhesive tabs that is/are attached to the nasogastric tube (placed through a nostril and via the oesophagus) to hold it safely and comfortably in place. The lock-ring or tabs can be removed without scissors for easy removal of the tube. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00842071115937 | GS1 | Box (4-421618) | 5 | In Commercial Distribution | |
| Primary | 00842071115890 | GS1 |
Customer Contacts
- Phone
- (440) 717-4000
- [email protected]
Premarket Submissions
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Catheter Gauge | 16 | French | |
| Catheter Gauge | 18 | French |