FDA UDI
In Commercial Distribution
🇺🇸 United States
HMS System™
DI: EBES8200090
·
Model: 820009
·
Boston Medical Products, Inc.
Product Codes
1
GMDN Terms
2
Identifiers
2
Pkg Device Count
1
Let the assistant research this device
The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.
Free to try · every answer cites its records
Basic Information
- Brand Name
- HMS System™
- Primary DI
- EBES8200090
- Version / Model
- 820009
- Catalog Number
- 820009
- Company Name
- Boston Medical Products, Inc.
- Labeler DUNS
- 131855157
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-09-20
- Public Version
- 4
- Public Version Date
- 2022-08-30
- Public Version Status
- Update
- Public Device Record Key
- c1a927be-d4d2-469b-b1c0-a720404aa0f3
Device Description
Size: 9 mm; Type: White
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- 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 |
| 57897 | Tracheostomy tube lubricant | A non-sterile substance made of oil (e.g., paraffin) designed to be applied by healthcare staff or a patient to the outer surface of a tracheostomy tube inner cannula to facilitate its easy sliding into the outer cannula (e.g., after cleaning). The lubrication is intended to reduce frictional forces so that less physical force is required for inner cannula insertion and to help prolong the life of the tube's cannulae. It is typically available in a squeeze or dropper bottle. After application, this device cannot be reused. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | EBES8200090 | HIBCC | ||||
| Package | EBES8200091 | HIBCC | Carton | 1 | In Commercial Distribution |
Customer Contacts
- Phone
- 1-800-433-2674
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K912290 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Length (Outer Limb): 45 mm | ||
| Device Size Text, specify | Outer Diameter (Outer Limb): 9 mm | ||
| Device Size Text, specify | Length (Lower Inner Limb): 37 mm | ||
| Device Size Text, specify | Length (Upper Inner Limb): 50 mm | ||
| Device Size Text, specify | Length (Inner Limb): 100 mm | ||
| Device Size Text, specify | Outer Diameter (Inner Limb): 9 mm |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep dry
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep away from sunlight