FDA UDI
In Commercial Distribution
🇺🇸 United States
Cook
DI: 00827002554580
·
Model: G55458
·
Cook Vandergrift Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Cook
- Primary DI
- 00827002554580
- Version / Model
- G55458
- Catalog Number
- DP-M350-CHG1
- Company Name
- Cook Vandergrift Inc.
- Labeler DUNS
- 056867526
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 4
- Public Version Date
- 2020-02-06
- Public Version Status
- Update
- Public Device Record Key
- 4f79993b-070e-45db-b4cb-adf9c9d722dc
Device Description
Charger For Blood Flow Monitor - DP-M350 - Non-Sterile
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- 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
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| JOP | TRANSDUCER, ULTRASONIC | Cardiovascular | 870.2880 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 17115 | Noninvasive device battery charger | An electrically-powered device designed to supply an electrical charge, via a direct/wired or wireless connection, to the battery of a noninvasive device to recharge it for operation; it is not intended to receive data from and transmit data to other devices (i.e., not a transceiver). It is typically in the form of an electronic circuitry housing with a cable. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00827002554580 | GS1 |
Customer Contacts
- Phone
- +1(812)330-5494
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store in dark, dry, cool place. Temperature limits to which the medical device can be safely exposed is -40 to +60 degrees Celsius. Humidity limitation - Non-condensing environment.