FDA UDI
In Commercial Distribution
🇺🇸 United States
LMA ATOMIZATION
DI: 14026704626554
·
Model: IPN049183
·
TELEFLEX INCORPORATED
Product Codes
1
GMDN Terms
1
Identifiers
4
Pkg Device Count
1
Basic Information
- Brand Name
- LMA ATOMIZATION
- Primary DI
- 14026704626554
- Version / Model
- IPN049183
- Catalog Number
- MAD510
- Company Name
- TELEFLEX INCORPORATED
- Labeler DUNS
- 002348191
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-02-15
- Public Version
- 5
- Public Version Date
- 2023-07-19
- Public Version Status
- Update
- Public Device Record Key
- 733882a9-40a1-4fb6-899b-4304c60dfe8d
Device Description
MADomizer Disposable 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
- 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
- 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 |
|---|---|---|---|---|
| CCQ | NEBULIZER, MEDICINAL, NON-VENTILATORY (ATOMIZER) | Anesthesiology | 868.5640 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 10226 | Atomizer, non-ventilatory | A non-powered, non-ventilatory device intended to provide liquid medication in an aerosolized airborne form for a patient to breathe. It is typically hand-operated. Unlike a nebulizer this devices lacks a baffle, therefore the particle size of the aerosol is not stabilized. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 24026704626551 | GS1 | Bag in Box | 50 | In Commercial Distribution | |
| Primary | 14026704626554 | GS1 | ||||
| Package | 34026704626558 | GS1 | Case | 4 | In Commercial Distribution | |
| Previous | 05060112313134 | GS1 |
Customer Contacts
- Phone
- +1(919)544-8000
- [email protected]