FDA UDI
In Commercial Distribution
🇺🇸 United States
Ambu
DI: 10889483231616
·
Model: 900-000-628
·
SUNMED, LLC
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
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Basic Information
- Brand Name
- Ambu
- Primary DI
- 10889483231616
- Version / Model
- 900-000-628
- Catalog Number
- 900-000-628
- Company Name
- SUNMED, LLC
- Labeler DUNS
- 069009268
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-12-19
- Public Version
- 2
- Public Version Date
- 2026-04-20
- Public Version Status
- Update
- Public Device Record Key
- 8c6e6b6b-feb6-4e6e-b071-9be22dbadb64
Device Description
Ambu Disposable Hyperinflation System, Hyperinflation System, 1 L Bag, 7' O2 and Manometer, 40 cm H2O Pop-Off Valve with Override
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 |
|---|---|---|---|---|
| BZR | Mixer, Breathing Gases, Anesthesia Inhalation | Anesthesiology | 868.5330 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37706 | Ventilator breathing circuit, single-use | An assembly of devices designed to conduct air or oxygen (O2) enriched gases and additional gases [e.g., nitrous oxide (N2O), halogenated gases] from a ventilator to a patient artificial airway/respiratory mask (not included). It includes breathing tubes, a Y-piece connector, and provides connections for devices that humidify, deliver medication, and monitor gas concentration or pressure within the breathing circuit; some types may include a carbon dioxide cuvette and/or an integrated heating wire powered by a connected humidifier intended to warm breathing gases as they enter the patient's airway. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20889483231613 | GS1 | Box | 12 | In Commercial Distribution | |
| Primary | 10889483231616 | GS1 | ||||
| Previous | 05707480137640 | GS1 |
Customer Contacts
- Phone
- 1-800-433-2797
- [email protected]