FDA UDI
In Commercial Distribution
🇺🇸 United States
AirLife
DI: 10885403171383
·
Model: 7166-HS7
·
Carefusion Corporation
Product Codes
1
GMDN Terms
3
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- AirLife
- Primary DI
- 10885403171383
- Version / Model
- 7166-HS7
- Catalog Number
- 7166-HS7
- Company Name
- Carefusion Corporation
- Labeler DUNS
- 830432451
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-01
- Public Version
- 8
- Public Version Date
- 2022-11-28
- Public Version Status
- Update
- Public Device Record Key
- e7286243-27a8-4aac-b7e2-195a04e654bf
Device Description
Airlife™ Isothermal™ Breathing Circuit Adult Respiratory Circuit Heated
Device Characteristics
- Single Use
- Yes
- 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
- Yes
- 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 |
|---|---|---|---|---|
| BZE | HEATER, BREATHING SYSTEM W/WO CONTROLLER (NOT HUMIDIFIER OR NEBULIZER | Anesthesiology | 868.5270 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35112 | Tracheal hook | A double-ended surgical instrument designed to hold the trachea steady during the creation of a tracheostoma and/or for separating/drawing aside the margins of a tracheostoma to assist in the insertion of a tracheostomy tube. It can be of various designs, e.g., double or single-ended with one end forming a broad bladed retractor and the opposite end tapers to form a pointed hook formed at various angles or multiple parallel hooks. It is made of high-grade stainless steel. This is a reusable device. | No | Obsolete |
| 37706 | Ventilator breathing circuit, single-use | An assembly of devices designed to conduct air or oxygen (O2) enriched gases and additional gases [e.g., nitrous oxide (N2O), halogenated gases] from a ventilator to a patient artificial airway/respiratory mask (not included). It includes breathing tubes, a Y-piece connector, and provides connections for devices that humidify, deliver medication, and monitor gas concentration or pressure within the breathing circuit; some types may include a carbon dioxide cuvette and/or an integrated heating wire powered by a connected humidifier intended to warm breathing gases as they enter the patient's airway. This is a single-use device. | No | Active |
| 61346 | Straight/elbow breathing circuit connector, single-use | A device intended to create a direct connection between a breathing circuit breathing tube and an endotracheal (ET) tube, anaesthesia face mask, or other non-sampling breathing circuit component. It is constructed with specific connecting dimensions and may be designed to connect breathing tubes from paediatric to adult sizes. It is typically made of plastic materials and can have a straight or elbow-shaped design (excludes Y-piece connectors). Some designs may allow for partial rotation at the point of connection (a swivel) and may include a suction port or gas sampling port. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 50885403171381 | GS1 | Case | 20 | In Commercial Distribution | |
| Primary | 10885403171383 | GS1 |
Customer Contacts
- Phone
- +1(800)323-9088
- [email protected]