FDA UDI
In Commercial Distribution
🇺🇸 United States
AEROECLIPSE II Breath Actuated Nebulizer without Oxygen Tubing
DI: 00762860055421
·
Model: 105542
·
Trudell Medical International
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
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Basic Information
- Brand Name
- AEROECLIPSE II Breath Actuated Nebulizer without Oxygen Tubing
- Primary DI
- 00762860055421
- Version / Model
- 105542
- Company Name
- Trudell Medical International
- Labeler DUNS
- 203298203
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-01-03
- Public Version
- 1
- Public Version Date
- 2020-01-13
- Public Version Status
- New
- Public Device Record Key
- e8912418-27a6-4ac7-89bb-5988484d7644
Device Description
AEROECLIPSE II Breath Actuated Nebulizer without Oxygen Tubing
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
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- 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
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| CAF | Nebulizer (Direct Patient Interface) | Anesthesiology | 868.5630 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62042 | Nebulizing system delivery set, reusable | A collection of non-sterile devices intended to be connected to a nebulizer system gas compressor or medical gas outlet to create/deliver an aerosol, usually medicated, to the patients respiratory system. It typically includes flexible tubing with connectors, a mask or mouthpiece, and a nebulizing medication chamber; pharmaceuticals are not included. This is a single-patient, reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10762860055428 | GS1 | 50 | In Commercial Distribution | ||
| Primary | 00762860055421 | GS1 | ||||
| Previous | 62860105542023 | GS1 |
Customer Contacts
- Phone
- 1-519-455-4862
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K053605 | 000 |