FDA UDI
In Commercial Distribution
🇺🇸 United States
American Medicals
DI: B356BF37002S0
·
Model: 1
·
American Medicals
Product Codes
1
GMDN Terms
1
Identifiers
1
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
- American Medicals
- Primary DI
- B356BF37002S0
- Version / Model
- 1
- Company Name
- American Medicals
- Labeler DUNS
- 109909627
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-09-15
- Public Version
- 2
- Public Version Date
- 2025-04-28
- Public Version Status
- Update
- Public Device Record Key
- 3f48b93b-0b69-45f7-8b12-946a0cf8fd40
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Microwave Radiation
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| CCW | Laryngoscope, Rigid | Anesthesiology | 868.5540 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 67482 | Rigid bladed intubation laryngoscope, optical, reusable | A hand-held device intended for the visual examination of the trachea, and to manipulate the tongue, preventing it from obstructing the oropharynx and enabling a clear view of the trachea for the insertion of an endotracheal (ET) tube prior to the delivery of inhalation anaesthesia and/or ventilation. It features a curved or straight blade of various designs and lengths that can be hinged/interchanged or integral. Anatomical images are transmitted to an eyecup at the proximal end of the device through relayed lens optics or a fibreoptic bundle; it may additionally be used in conjunction with a digital camera/screen (not included). This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B356BF37002S0 | HIBCC |