FDA UDI
In Commercial Distribution
🇺🇸 United States
N/A
DI: 04710810119620
·
Model: BR30/AN0003
·
GALEMED CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- N/A
- Primary DI
- 04710810119620
- Version / Model
- BR30/AN0003
- Catalog Number
- AN0003
- Company Name
- GALEMED CORPORATION
- Labeler DUNS
- 656854379
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-12-01
- Public Version
- 1
- Public Version Date
- 2025-12-09
- Public Version Status
- New
- Public Device Record Key
- bf143bb3-6ae1-4ae2-8f65-de66017d7281
Device Description
nBag Resuscitator
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
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| BTM | Ventilator, Emergency, Manual (Resuscitator) | Anesthesiology | 868.5915 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36086 | Pulmonary resuscitator, manual, single-use | A non-sterile, hand-operated device designed to provide or assist ventilation in patients who are apnoeic or exhibit inadequate respiration. It typically employs entrained ambient air and includes a large flexible chamber that is hand-ventilated, a gas reservoir, tubing, and a connector for attachment to a mask or endotracheal (ET) tube; oxygen (O2) from an O2 source may also be connected when necessary. It is used used by emergency medical services (EMS) in ambulances, intensive care units (ICU), during internal patient transfer, accident and emergency (A&E), mass casualty incidents (MCI), and is generally placed strategically throughout a hospital. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 44710810119628 | GS1 | Carton | 12 | In Commercial Distribution | |
| Primary | 04710810119620 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K112852 | 000 |