Cook
- Primary DI
- 00827002516076
- Company
- COOK INCORPORATED
- Model
- G51607
- Catalog number
- K-MAR-5200-US
- Device description
- Cook, Aspiration Unit
- Published
- 2016-09-24
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- true
- Single use
- true
Regulatory Flags
- DUNS number
- 042823948
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- true
- Expiration date on label
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
Identifiers
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 00827002516076 | Primary | GS1 | 0 | |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Package type | Contains DI | Discontinue date | Status |
|---|
| 00827002516076 | Primary | GS1 | 0 | | | | |
Product Codes
| Code | Name | Class | Specialty | Regulation | Implant | Malfunction reporting |
|---|
| MQG | Accessory, Assisted Reproduction | 2 | Obstetrics/Gynecology | 884.6120 | N | Eligible |
Premarket Details
| Submission | Supplement | Device | Applicant | Decision date | Product code |
|---|
| K160753 | 000 | COOK Vacuum Pump | William A. Cook Australia Pty. , Ltd. | 2017-06-13 | MQG |
| K992070 | 000 | COOK ULTRA QUIET VACUUM PUMP & REGULATOR | Cook Urological, Inc. | 1999-10-27 | MQG |
GMDN Terms
| Term | Definition |
|---|
| General-purpose suction system, line-powered | An assembly of devices designed to evacuate fluid, tissue, gas, or other foreign materials from a body cavity or lumen by means of suction. It generally consists of a mains electricity (AC-powered) suction pump, tubing, plastic/glass collection container(s), a vacuum gauge, a vacuum control knob, an overflow trap, a moisture filter, and possibly a microbial filter. The pump creates a vacuum in the suction tubing, which is inserted into the body for the removal of materials into the collection container. This system can be used in a wide variety of settings within healthcare facilities. |
Device Sizes
No records found.
Storage And Handling
| Type | Low | High | Condition |
|---|
| Special Storage Condition, Specify | 0 | 0 | Store in dark, dry, cool place |
| Special Storage Condition, Specify | 0 | 0 | Store in dark, dry, cool place. |
Contacts
| Phone | Email |
|---|
| +1(812)330-5494 | sharedservices@cookmedical.com |
Other Devices From This Company
Other Devices Sharing Product Codes