FDA UDI
In Commercial Distribution
🇺🇸 United States
andorate® Air/Water Bottle Tubing with CO2 Extend
DI: 04897106950140
·
Model: GAR088CO2EXTUS
·
GA Health Company Limited
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
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Basic Information
- Brand Name
- andorate® Air/Water Bottle Tubing with CO2 Extend
- Primary DI
- 04897106950140
- Version / Model
- GAR088CO2EXTUS
- Company Name
- GA Health Company Limited
- Labeler DUNS
- 686908512
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-05-28
- Public Version
- 5
- Public Version Date
- 2023-10-16
- Public Version Status
- Update
- Public Device Record Key
- 76e095a5-045f-4fb8-9571-a235f3dd7894
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
- Yes
- 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 |
|---|---|---|---|---|
| OCX | Endoscopic Irrigation/Suction System | Gastroenterology, Urology | 876.1500 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60738 | Endoscopic insufflation tubing set, single-use | A collection of flexible tubing intended to channel medical gas [e.g., carbon dioxide (CO2), medical air] from its source into a body cavity for insufflation during endoscopy (e.g., gastrointestinal endoscopy, laparoscopy, arthroscopy). It includes synthetic polymer tubing and associated connectors; it may in addition be intended for endoscopic lens drying, and may include additional tubing for delivery of a sterile irrigation solution for endoscopic irrigation. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 14897106950147 | GS1 | Box | 10 | In Commercial Distribution | |
| Primary | 04897106950140 | GS1 | ||||
| Package | 24897106950144 | GS1 | Carton | 4 | In Commercial Distribution |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K200388 | 000 |