FDA UDI
In Commercial Distribution
🇺🇸 United States
PUMA-G System™
DI: 00850026037180
·
Model: 0010356
·
Coaptech, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- PUMA-G System™
- Primary DI
- 00850026037180
- Version / Model
- 0010356
- Catalog Number
- 0010359
- Company Name
- Coaptech, Inc.
- Labeler DUNS
- 080322442
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-07-13
- Public Version
- 3
- Public Version Date
- 2024-02-13
- Public Version Status
- Update
- Public Device Record Key
- 381caafb-a8e3-45a4-b416-66ca965a1a53
Device Description
Percutaneous Ultrasound Gastrostomy (PUG) System Balloon Catheter
Device Characteristics
- Single Use
- Yes
- 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
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KGC | Tube, Gastro-Enterostomy | Gastroenterology, Urology | 876.5980 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64057 | Ultrasound-guided gastrostomy system catheter | A sterile, flexible, tubular device with an inflatable balloon and a magnet at its distal end intended to be placed in the stomach, via the oesophagus, and used to move the stomach to the anterior abdominal wall via attraction by an external magnet (not included), to facilitate a gastrostomy. The balloon is filled with a fluid (e.g., saline) to enable detection by an ultrasound imaging system (not included) for its optimal placement without intervention of other anatomical structures (e.g., organs, vessels). Devices dedicated to catheter introduction/function (e.g., introducer needle, guidewire) may be included. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10850026037187 | GS1 | Shipper Box | 2 | In Commercial Distribution | |
| Primary | 00850026037180 | GS1 |
Customer Contacts
- Phone
- 1 443 574 6934
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 0 – 60 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- 25 – 75 Percent (%) Relative Humidity
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store away from other magnetic material