FDA UDI
In Commercial Distribution
🇺🇸 United States
Micro Cirrus nebuliser anti-pollution kit with mouthpiece, filter and tube
DI: 00816472020244
·
Model: 14176000
·
Intersurgical Incorporated
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Micro Cirrus nebuliser anti-pollution kit with mouthpiece, filter and tube
- Primary DI
- 00816472020244
- Version / Model
- 14176000
- Company Name
- Intersurgical Incorporated
- Labeler DUNS
- 785952607
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-11-30
- Public Version
- 2
- Public Version Date
- 2025-02-11
- Public Version Status
- Update
- Public Device Record Key
- 02200100-7136-43dc-840f-48369a78b97a
Device Description
Micro Cirrus nebuliser anti-pollution kit with mouthpiece, filter and tube
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Safe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| CAF | Nebulizer (Direct Patient Interface) | Anesthesiology | 868.5630 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 31309 | Nebulizing system delivery set, single-use | A collection of flexible tubing, typically non-sterile, and associated items that may include a mask or mouthpiece, a medication chamber, and connectors, used with a nebulizer to deliver an aerosol, usually medicated, to the patient's respiratory system. It is made of synthetic material and is typically a thick-walled, anti-kink tubing to prevent blockage. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00816472020251 | GS1 | 20 | In Commercial Distribution | ||
| Primary | 00816472020244 | GS1 |
Customer Contacts
- Phone
- 13154512900
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K911422 | 000 |