FDA UDI
In Commercial Distribution
🇺🇸 United States
ResQPOD ITD 16
DI: 00847946026943
·
Model: 12-0822-000
·
Zoll Medical Corporation
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ResQPOD ITD 16
- Primary DI
- 00847946026943
- Version / Model
- 12-0822-000
- Company Name
- Zoll Medical Corporation
- Labeler DUNS
- 055363428
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-06-24
- Public Version
- 1
- Public Version Date
- 2020-07-02
- Public Version Status
- New
- Public Device Record Key
- 6cc531e5-b029-4822-8a39-a99dcfc687e5
Device Description
RESQPOD ITD 16, US
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 |
|---|---|---|---|---|
| PIZ | Combination compression/decompression manual chest pump with impedance respiratory valve | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 17169 | Demand valve | A non-sterile device that is used to regulate the therapeutic gas flow to a patient in response to the patient's breathing effort. It is used, e.g., in ventilator breathing circuits, resuscitation devices and in on demand analgesia devices. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00847946026943 | GS1 |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- -18 – 50 Degrees Celsius
- Type
- Storage Environment Temperature
- Temperature Range
- -40 – 60 Degrees Celsius
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- Low: 0 KiloPascal
- Type
- Storage Environment Humidity
- Temperature Range
- 0 – 0 Percent (%) Relative Humidity