FDA UDI
In Commercial Distribution
🇺🇸 United States
Merlyn EndoTube
DI: 00182151000037
·
Model: Oral/Nasal 401035
·
MERLYN ASSOCIATES, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Merlyn EndoTube
- Primary DI
- 00182151000037
- Version / Model
- Oral/Nasal 401035
- Catalog Number
- 401035
- Company Name
- MERLYN ASSOCIATES, INC.
- Labeler DUNS
- 606864184
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-06-01
- Public Version
- 4
- Public Version Date
- 2020-06-19
- Public Version Status
- Update
- Public Device Record Key
- 71f36a0b-b3a1-47c2-ae5f-97fb1e4411b3
Device Description
3.5mm ID oral/nasal endotracheal tube with inflatable cuff, Magill curve, radiopaque line and smooth Murphy tip
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- Yes
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| 46967 | Basic endotracheal tube, single-use | A hollow cylinder inserted orally or nasally into the trachea to provide an unobstructed airway to convey gases and vapours to and from the lungs during anaesthesia, resuscitation, and other situations where the patient is not properly ventilated; it does not include an antimicrobial agent(s). The device may: 1) be packaged with a connector that will attach to a breathing circuit or manual resuscitator; 2) have a distal inflatable cuff to seal against the tracheal wall; 3) be radiopaque; and 4) have a built-in pilot balloon for cuff pressure monitoring. It is available in various diameters and lengths for adult and paediatric patients. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10182151000034 | GS1 | inner carton | 10 | In Commercial Distribution | |
| Primary | 00182151000037 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K042683 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Lumen/Inner Diameter | 3.5 | Millimeter |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- 32 – 120 Degrees Fahrenheit