FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Hebeler Safe-T-Tube™
DI: EBES4500150
·
Model: 450015
·
Boston Medical Products, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Hebeler Safe-T-Tube™
- Primary DI
- EBES4500150
- Version / Model
- 450015
- Catalog Number
- 450015
- Company Name
- Boston Medical Products, Inc.
- Labeler DUNS
- 131855157
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-09-20
- Public Version
- 3
- Public Version Date
- 2022-08-30
- Public Version Status
- Update
- Public Device Record Key
- 96e3d7db-37ae-4b37-abde-4da3c94c4d99
- Distribution End Date
- 2016-04-15
Device Description
Size: 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
- Labeling does not contain MRI Safety Information
- 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
- Yes
- 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 |
|---|---|---|---|---|
| 35458 | Trachea prosthesis | An implantable artificial substitute for the natural trachea used in airway reconstructive surgery. It is typically a semi-rigid, flexible, or expandable tubular device made of a silicone, metal, or polymeric material that is intended to be implanted to restore the structure and/or function of the trachea or trachealbronchial tree. It may be unbranched or contain one or two branches. The metal trachea prosthesis may be uncovered or covered with a polymeric material. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | EBES4500150 | HIBCC | ||||
| Package | EBES4500151 | HIBCC | Carton | 1 | Not in Commercial Distribution | 2016-04-15 |
Customer Contacts
- Phone
- 1-800-433-2674
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Length (Outer Limb): 59 mm | ||
| Device Size Text, specify | Outer Diameter (Outer Limb): 12 mm | ||
| Device Size Text, specify | Length (Lower Inner Limb): 40 mm | ||
| Device Size Text, specify | Length (Upper Inner Limb): 25 mm | ||
| Device Size Text, specify | Length (Inner Limb): 77 mm | ||
| Device Size Text, specify | Outer Diameter (Inner Limb): 15 mm |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep dry
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep away from sunlight