FDA UDI
In Commercial Distribution
🇺🇸 United States
ResQGARD FM Kit
DI: 00847946026936
·
Model: 12-0707-000
·
Zoll Medical Corporation
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ResQGARD FM Kit
- Primary DI
- 00847946026936
- Version / Model
- 12-0707-000
- 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
- 4
- Public Version Date
- 2023-06-22
- Public Version Status
- Update
- Public Device Record Key
- f620997d-9dde-4048-aeca-15c9b0795f51
Device Description
RESQGARD FM KIT
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 |
|---|---|---|---|---|
| BWF | SPIROMETER, THERAPEUTIC (INCENTIVE) | Anesthesiology | 868.5690 | 2 |
| JOW | SLEEVE, LIMB, COMPRESSIBLE | Cardiovascular | 870.5800 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35693 | Cardiopulmonary resuscitation kit, single-use | A collection of items in a portable case intended for cardiopulmonary resuscitation (e.g., emergency pharmaceuticals, airway tubes, face masks or resuscitator). It is typically placed in a convenient location in public buildings and in EMS vehicles for quick access in emergency situations. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00847946026936 | GS1 |
Storage Conditions
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- Low: 0 KiloPascal
- Type
- Handling Environment Temperature
- Temperature Range
- -18 – 50 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- 0 – 0 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- -40 – 60 Degrees Celsius