FDA UDI
In Commercial Distribution
🇺🇸 United States
FLY
DI: 06971082850088
·
Model: FLY-BT-102
·
Shanghai FLY Medical Devices Co., Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- FLY
- Primary DI
- 06971082850088
- Version / Model
- FLY-BT-102
- Company Name
- Shanghai FLY Medical Devices Co., Ltd.
- Labeler DUNS
- 544492194
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-03-29
- Public Version
- 3
- Public Version Date
- 2023-06-05
- Public Version Status
- Update
- Public Device Record Key
- dde59f66-5af3-428c-84f8-80abcb3eb8b2
Device Characteristics
- Single Use
- Yes
- 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
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FCY | Bulb, Inflation, For Endoscope | Gastroenterology, Urology | 876.1500 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35800 | Endoscope inflation bulb | A device that is used in conjunction with an endoscope and its direct application and which assists in the use of the endoscope. It is a dedicated device shaped as a rubber bulb which is used to feed air via the endoscope to obtain an endoscopic view of the site. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 06971082850088 | GS1 | ||||
| Package | 16971082850153 | GS1 | 100 | In Commercial Distribution |