FDA UDI
In Commercial Distribution
🇺🇸 United States
Tactical Medical Module-Airway (TMM-AW)
DI: 00850018201377
·
Model: 01381
·
Altitude Technologies Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Tactical Medical Module-Airway (TMM-AW)
- Primary DI
- 00850018201377
- Version / Model
- 01381
- Catalog Number
- 01381
- Company Name
- Altitude Technologies Inc.
- Labeler DUNS
- 621904622
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-05-20
- Public Version
- 2
- Public Version Date
- 2023-06-13
- Public Version Status
- Update
- Public Device Record Key
- f56e90c6-675a-4ff3-af55-ad1ea1f338cf
Device Description
The TMM-AW provides the basic airway adjuncts necessary to establish a patent airway, including a King LTS-D supraglottic airway device.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| CAE | Airway, Oropharyngeal, Anesthesiology | Anesthesiology | 868.5110 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45036 | Laryngeal mask airway, single-use | A curved tube with a distal inflatable cuff/mask intended to be used in inhalational anaesthesia and resuscitation to facilitate and secure airway patency for the delivery and exchange of gases in spontaneously breathing and ventilated patients. It is inserted into the hypopharynx above the glottis to create a seal and to prevent the tongue from obstructing the anatomical airway. It may include a 15 mm connector that attaches to a breathing circuit or manual resuscitator, be radiopaque, and have a built-in pilot balloon for cuff pressure monitoring. It is available in various sizes/designs and is typically made of silicone/plastic materials. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850018201377 | GS1 |
Customer Contacts
- Phone
- 800.766.1365
- [email protected]