FDA UDI
In Commercial Distribution
🇺🇸 United States
Babi.Plus
DI: 04710810100802
·
Model: BC23-HD
·
GALEMED CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
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Basic Information
- Brand Name
- Babi.Plus
- Primary DI
- 04710810100802
- Version / Model
- BC23-HD
- Catalog Number
- 12.5 cm H2O Pressure Relief Manifold with Gas Supply Tube and Oxygen Sensor Port
- Company Name
- GALEMED CORPORATION
- Labeler DUNS
- 656854379
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-09-24
- Public Version
- 4
- Public Version Date
- 2024-10-24
- Public Version Status
- Update
- Public Device Record Key
- 013bd926-8578-4a56-aa77-26aa281f20c0
Device Description
Distributed by Teleflex
Device Characteristics
- Single Use
- No
- 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
- No
- 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 |
|---|---|---|---|---|
| BZD | Ventilator, Non-Continuous (Respirator) | Anesthesiology | 868.5905 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 16803 | Ventilator IMV supplemental circuit, single-use | A device designed to provide mandatory breathes to ventilator patients to supplement the spontaneous respiratory rate. It is typically constructed of plastics and consists of tubing and one-way valves. It will be used as an accessory on older ventilators without built-in intermittent mandatory ventilation (IMV) functions. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 44710810100800 | GS1 | Carton | 2 | In Commercial Distribution | |
| Package | 24710810100806 | GS1 | Box | 12 | In Commercial Distribution | |
| Primary | 04710810100802 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K110383 | 000 |