FDA UDI
In Commercial Distribution
🇺🇸 United States
Mark IV Baby Resuscitator
DI: 05707480035243
·
Model: 299006000
·
Ambu A/S
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Mark IV Baby Resuscitator
- Primary DI
- 05707480035243
- Version / Model
- 299006000
- Catalog Number
- 299006000
- Company Name
- Ambu A/S
- Labeler DUNS
- 305682023
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-12-19
- Public Version
- 3
- Public Version Date
- 2024-09-24
- Public Version Status
- Update
- Public Device Record Key
- 41c77e35-5a62-40a9-8845-fc09c9fe7f78
Device Description
Resuscitator with Reservoir Bag
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
- No
- MRI Safety
- MR Conditional
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| OEV | Cardiopulmonary resuscitation aid kit | Anesthesiology | 868.5915 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36690 | Cardiopulmonary resuscitation kit, reusable | A collection of items in a portable case intended for cardiopulmonary resuscitation (e.g., airway tubes, face masks, resuscitator). It is typically placed in a convenient location in public buildings and in emergency medical services (EMS) vehicles for quick access in emergency situations. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05707480035243 | GS1 | ||||
| Package | 05707480019564 | GS1 | 12 | In Commercial Distribution |
Customer Contacts
- Phone
- +14107686464
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Baby |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- -18 – 50 Degrees Celsius
- Type
- Storage Environment Temperature
- Temperature Range
- -18 – 50 Degrees Celsius