FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Oval Silicone Resuscitator, Neonate
DI: 05707480035151
·
Model: A288001000
·
Ambu A/S
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Oval Silicone Resuscitator, Neonate
- Primary DI
- 05707480035151
- Version / Model
- A288001000
- Catalog Number
- A288001000
- Company Name
- Ambu A/S
- Labeler DUNS
- 305682023
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-12-19
- Public Version
- 3
- Public Version Date
- 2024-12-20
- Public Version Status
- Update
- Public Device Record Key
- 4e4fde1f-9101-4074-a8f9-eb8d71aa99af
- Distribution End Date
- 2024-12-19
Device Description
Ambu Oval Silicone Neonate Resuscitator with pressure limiting valve (40cm H20) with Ambu single shutter patient valve and oxygen reservoir tube. Supplied in pouch & carton.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- No
- 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 |
|---|---|---|---|---|
| BTM | Ventilator, emergency, manual (resuscitator) | Anesthesiology | 868.5915 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 17591 | Pulmonary resuscitator, manual, reusable | A 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 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 reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05707480035151 | GS1 | ||||
| Package | 05707480016914 | GS1 | 12 | Not in Commercial Distribution | 2024-12-19 |
Customer Contacts
- Phone
- +14107686464
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Neonate |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -40 – 60 Degrees Celsius
- Type
- Handling Environment Temperature
- Temperature Range
- -18 – 50 Degrees Celsius