FDA UDI
Not in Commercial Distribution
🇺🇸 United States
AEROCHAMBER mini Holding Chamber
DI: 62860875010029
·
Model: 875010
·
Trudell Medical International
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
10
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Basic Information
- Brand Name
- AEROCHAMBER mini Holding Chamber
- Primary DI
- 62860875010029
- Version / Model
- 875010
- Catalog Number
- 87594010
- Company Name
- Trudell Medical International
- Labeler DUNS
- 203298203
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 10
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 5
- Public Version Date
- 2020-04-23
- Public Version Status
- Update
- Public Device Record Key
- 5651120a-ed10-4943-82a4-eeea5699d8cd
- Distribution End Date
- 2020-04-22
Device Description
AEROCHAMBER mini Holding Chamber
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
- 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 |
|---|---|---|---|---|
| 35122 | Metered dose inhaler | A hand-held device designed to administer a pre-measured dose of aerosolized medication directly into the mouth of a patient. It typically consists of a shaped plastic holder with integrated mouthpiece into which a pressurized metal canister containing the solution or suspension of medicine is placed. Commonly known as a metered dose inhaler (MDI), aerosol inhaler or puffer, it is a portable device typically carried in the pocket or a handbag (purse) of the patient for convenient access. A medicine chamber spacer may be attached to this device to facilitate its use by small children (enables the slow inhalation of the medicine). This is a reusable device intended for single-patient use. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 62860875010029 | GS1 | ||||
| Unit of Use | 62860875010012 | GS1 |
Customer Contacts
- Phone
- 1-519-455-4862
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K090065 | 000 |