FDA UDI
In Commercial Distribution
🇺🇸 United States
LMA AIRWAY MANAGEMENT
DI: 25060112314739
·
Model: IPN915395
·
TELEFLEX INCORPORATED
Product Codes
1
GMDN Terms
1
Identifiers
4
Pkg Device Count
1
Basic Information
- Brand Name
- LMA AIRWAY MANAGEMENT
- Primary DI
- 25060112314739
- Version / Model
- IPN915395
- Catalog Number
- 130099
- Company Name
- TELEFLEX INCORPORATED
- Labeler DUNS
- 002348191
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-08-11
- Public Version
- 1
- Public Version Date
- 2021-08-19
- Public Version Status
- New
- Public Device Record Key
- 1c2ec8fb-c68b-4f8a-b9e4-93f47ba39b45
Device Description
LMA Fastrach™ Stabiliser Rod
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Safe
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| CAE | AIRWAY, OROPHARYNGEAL, ANESTHESIOLOGY | Anesthesiology | 868.5110 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60376 | Endotracheal tube stabilization rod | A non-sterile device intended to be used to facilitate exchange of an in situ laryngeal airway for an endotracheal tube (ETT) by stabilizing the position of the inserted ETT as the laryngeal airway is withdrawn. It typically consists of a semi-flexible rod which functions as an extension of the ETT during the exchange. This is a reusable device intended to be sterilized prior to use. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 45060112314733 | GS1 | Carton | 10 | In Commercial Distribution | |
| Package | 35060112314736 | GS1 | Bag | 10 | In Commercial Distribution | |
| Primary | 25060112314739 | GS1 | ||||
| Direct Marking | 15060112314732 | GS1 |
Customer Contacts
- Phone
- +1(919)544-8000
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Dark cool environment avoid direct sunlight