FDA UDI
In Commercial Distribution
🇺🇸 United States
LMA
DI: 15060112312059
·
Model: IPN900350
·
TELEFLEX INCORPORATED
Product Codes
1
GMDN Terms
1
Identifiers
4
Pkg Device Count
10
Basic Information
- Brand Name
- LMA
- Primary DI
- 15060112312059
- Version / Model
- IPN900350
- Catalog Number
- 15499
- Company Name
- TELEFLEX INCORPORATED
- Labeler DUNS
- 002348191
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 10
- Record Status
- Published
- Publish Date
- 2018-09-15
- Public Version
- 2
- Public Version Date
- 2024-01-31
- Public Version Status
- Update
- Public Device Record Key
- 32fe31c5-e7df-4a1c-803c-12d2b7396aa9
Device Description
LMA ProSeal Cleaning Brushes
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
- 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
- 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 |
|---|---|---|---|---|
| 34883 | Airway device cleaning utensil, noninvasive, reusable | A hand-held device intended to be used to clean an ex situ non-endoscopic airway device [e.g., endotracheal (ET) tube, tracheoesophageal speech valve, laryngeal airway], once it has been removed from the patient, to remove organic matter (e.g., phlegm). It is in the form of a flexible or rigid handle with distal soft or stiff bristles, fibres or spines, or a swab; it may be used in the home or healthcare facility. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Direct Marking | 35060112312053 | GS1 | ||||
| Package | 25060112312056 | GS1 | Case | 50 | In Commercial Distribution | |
| Primary | 15060112312059 | GS1 | ||||
| Unit of Use | 45060112312050 | GS1 |
Customer Contacts
- Phone
- +1(919)544-8000
- [email protected]