FDA UDI
In Commercial Distribution
🇺🇸 United States
15 mm Adaptor
DI: 14063107100274
·
Model: 321127
·
Boston Medical Products, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- 15 mm Adaptor
- Primary DI
- 14063107100274
- Version / Model
- 321127
- Catalog Number
- 321127
- Company Name
- Boston Medical Products, Inc.
- Labeler DUNS
- 131855157
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-09-01
- Public Version
- 1
- Public Version Date
- 2022-09-09
- Public Version Status
- New
- Public Device Record Key
- 21a86378-ba3b-401e-bdbd-cb539bc8d7a6
Device Description
Size: 11-16 mm x 15 mm
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 |
|---|---|---|---|---|
| BTR | Tube, Tracheal (W/Wo Connector) | Anesthesiology | 868.5730 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47119 | Tracheostomy tube decannulation cap | A device designed to facilitate tracheostomy tube weaning and removal (decannulation), as well as voice restoration, for patients who have been chronic users of a tracheostomy tube. It is a small plastic cover (a cap), typically brightly coloured for easy identification, that is placed on the proximal end of a fenestrated or uncuffed tracheostomy tube to close the tracheostomy termination. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 34063107100278 | GS1 | Carton | 1 | In Commercial Distribution | |
| Primary | 14063107100274 | GS1 |
Customer Contacts
- Phone
- 1-800-433-2674
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K843936 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Fits Size 11-16 mm Montgomery® Safe-T-Tubes™ and 12 mm Hebeler Safe-T-Tubes™ |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep away from sunlight
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep dry