FDA UDI
In Commercial Distribution
🇺🇸 United States
ResQPUMP International
DI: 00847946028312
·
Model: 12-0582-000
·
Zoll Medical Corporation
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ResQPUMP International
- Primary DI
- 00847946028312
- Version / Model
- 12-0582-000
- 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
- 532b6824-a660-4824-be6c-e585a032eefe
Device Description
RESQPUMP INTERNATIONAL
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
- MR Unsafe
- 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 |
|---|---|---|---|---|
| 41882 | Cardiac resuscitator, manual | A manually-operated external device (a hand-powered pump) designed to be applied to the chest of a patient suffering cardiac arrest so that a healthcare professional or layperson can administer rhythmic compression to the chest in the region of the heart to provide blood flow during cardiopulmonary resuscitation (CPR). It typically consists of central piston, a soft but firm base, (a ring) that contacts the chest, a strong spiralled spring that transfers the users applied force to the piston, and a large handle for the user's hands. The compression force can be adjusted to a pre-set load to achieve equal delivered compressions to prevent damage to the ribs/organs. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00847946028312 | GS1 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -40 – 60 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- 0 – 0 Percent (%) Relative Humidity
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- Low: 0 KiloPascal
- Type
- Handling Environment Temperature
- Temperature Range
- -18 – 50 Degrees Celsius