FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Limb-O
DI: 10885403289859
·
Model: 5510
·
Carefusion Corporation
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Limb-O
- Primary DI
- 10885403289859
- Version / Model
- 5510
- Catalog Number
- 5510
- Company Name
- Carefusion Corporation
- Labeler DUNS
- 830432451
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-01
- Public Version
- 5
- Public Version Date
- 2024-05-21
- Public Version Status
- Update
- Public Device Record Key
- bfc2b583-b8f5-4e70-b533-c576c35b438c
- Distribution End Date
- 2022-03-31
Device Description
Limb-O™ Single Limb Anesthesia Breathing Circuit
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
- Yes
- 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 |
|---|---|---|---|---|
| BZO | SET, TUBING AND SUPPORT, VENTILATOR (W HARNESS) | Anesthesiology | 868.5975 | 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 | 50885403289857 | GS1 | Case | 20 | Not in Commercial Distribution | 2022-03-31 |
| Primary | 10885403289859 | GS1 |
Customer Contacts
- Phone
- +1(800)323-9088
- [email protected]