FDA UDI
In Commercial Distribution
🇺🇸 United States
OPTICHAMBER DIAMOND
DI: 00383730000329
·
Model: OPTICHAMBER DIAMOND - 10-PACK CANADA
·
RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
10
Basic Information
- Brand Name
- OPTICHAMBER DIAMOND
- Primary DI
- 00383730000329
- Version / Model
- OPTICHAMBER DIAMOND - 10-PACK CANADA
- Catalog Number
- 1098213
- Company Name
- RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD
- Labeler DUNS
- 220018415
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 10
- Record Status
- Published
- Publish Date
- 2016-08-24
- Public Version
- 4
- Public Version Date
- 2023-03-02
- Public Version Status
- Update
- Public Device Record Key
- 3c8a6a43-4421-4486-bcb3-95162467d1c4
Device Description
A holding chamber is a tube that attaches to the inhaler and holds the medication until the patient can breathe it in.
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 |
|---|---|---|---|---|
| 38018 | Medicine chamber spacer, reusable | A device intended to be placed between a nebulizer or a metered dose inhaler (MDI) and the patient's mouth, to function as a reservoir into which an aerosol medication is dispensed in order to minimize delivery of large aerosolized particles. It is typically made of plastic materials and in the form of a small tube-like container. By holding the drug(s) after aerosolization (e.g., via an internal valve) this device reduces the direct delivery of large aerosolized particles which would otherwise deposit in the mouth/upper airway, but are intended for the lower airway. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00383730000329 | GS1 | ||||
| Unit of Use | 00383735000553 | GS1 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -20 – 60 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- 15 – 95 Percent (%) Relative Humidity