FDA UDI
In Commercial Distribution
🇺🇸 United States
Vital Signs™
DI: 10889483603352
·
Model: M1154610
·
AirLife Finland Oy
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Vital Signs™
- Primary DI
- 10889483603352
- Version / Model
- M1154610
- Catalog Number
- M1154610
- Company Name
- AirLife Finland Oy
- Labeler DUNS
- 368457563
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-04-22
- Public Version
- 1
- Public Version Date
- 2025-04-30
- Public Version Status
- New
- Public Device Record Key
- 7a1b04c4-05ec-4b8f-b1c1-a34eca1ba9f2
Device Description
Vital Signs™ Manual Ventilation Tube for ABS Bag Arm, Expandable, Disposable, 1.8 m/72 in With ABS Bag Arm Connector
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
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| BYX | Tubing, Pressure And Accessories | Anesthesiology | 868.5860 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37704 | Anaesthesia breathing circuit, single-use | An assembly of devices designed to conduct medical gases from an anaesthesia unit/workstation to a patient artificial airway/anaesthesia mask (not included) during general anaesthesia. It includes breathing tubes and a Y-piece connector, typically with a ventilator/ventilation bag and appropriate connectors, and may include a carbon dioxide (CO2) absorber, a one-way directional valve, or adjustable pressure limiting (APL) valve. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20889483603359 | GS1 | Case | 30 | In Commercial Distribution | |
| Primary | 10889483603352 | GS1 |
Customer Contacts
- Phone
- (800)433-2797
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -20 – 40 Degrees Celsius
- Type
- Storage Environment Temperature
- Temperature Range
- -4 – 104 Degrees Fahrenheit