FDA UDI
In Commercial Distribution
🇺🇸 United States
CIRRUS2 NEBULISER, ADULT, INTERSURGICAL ECOLITE MASK KIT AND TUBE, 2.1M
DI: 05030267157914
·
Model: 1453014
·
Intersurgical Incorporated
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- CIRRUS2 NEBULISER, ADULT, INTERSURGICAL ECOLITE MASK KIT AND TUBE, 2.1M
- Primary DI
- 05030267157914
- Version / Model
- 1453014
- Company Name
- Intersurgical Incorporated
- Labeler DUNS
- 785952607
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-10-09
- Public Version
- 3
- Public Version Date
- 2025-12-08
- Public Version Status
- Update
- Public Device Record Key
- 4a36e911-7157-494e-8c69-aefb79bab565
Device Description
CIRRUS2 NEBULISER, ADULT, INTERSURGICAL ECOLITE MASK KIT AND TUBE WITH UNIVERSAL CONNECTOR, 2.1M
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- Yes
- 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
- 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 | 05030267163618 | GS1 | 30 | In Commercial Distribution | ||
| Primary | 05030267157914 | GS1 |
Customer Contacts
- Phone
- 3154512900
- [email protected]