FDA UDI
In Commercial Distribution
🇺🇸 United States
PATIENT CIRCUITS
DI: 00847946023232
·
Model: 712-0004-00
·
Zoll Medical Corporation
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- PATIENT CIRCUITS
- Primary DI
- 00847946023232
- Version / Model
- 712-0004-00
- Company Name
- Zoll Medical Corporation
- Labeler DUNS
- 055363428
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-09-06
- Public Version
- 6
- Public Version Date
- 2022-06-09
- Public Version Status
- Update
- Public Device Record Key
- a0b722c0-d3af-4f1c-8277-6922ee24044c
Device Description
KIT, CHILD, MASK # 4 / HARNESS, SINGLE
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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
- Yes
- 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 |
|---|---|---|---|---|
| CBK | VENTILATOR, CONTINUOUS, FACILITY USE | Anesthesiology | 868.5895 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36289 | Transport electric ventilator | An electrically-powered device designed to provide automated, alveolar ventilatory support for patients during interhospital or intrahospital transport, and in emergency situations. It is typically a compact, lightweight, rugged device with internal batteries to power it during patient transport. It typically provides mandatory breaths at pre-set intervals (control mode), not allowing the patient to breathe spontaneously; operation in assist/control and/or synchronized intermittent mandatory ventilation (SIMV) modes is available in some types. It usually includes an airway pressure monitor and low and high pressure alarms; it may be used in ambulances, and in field hospitals. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00847946023232 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K111473 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 0 – 0 Degrees Celsius
- Type
- Handling Environment Temperature
- Temperature Range
- 0 – 0 Degrees Celsius
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- Low: 0 KiloPascal
- Type
- Storage Environment Humidity
- Temperature Range
- 0 – 0 Percent (%) Relative Humidity