FDA UDI
In Commercial Distribution
🇺🇸 United States
EpiFaith Syringe
DI: 04719875599026
·
Model: FM-02SNR
·
Flat Medical Co., Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- EpiFaith Syringe
- Primary DI
- 04719875599026
- Version / Model
- FM-02SNR
- Company Name
- Flat Medical Co., Ltd.
- Labeler DUNS
- 656303754
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-07-07
- Public Version
- 5
- Public Version Date
- 2023-02-09
- Public Version Status
- Update
- Public Device Record Key
- b02a71a9-8cb9-457e-ace6-27ba414fa8f3
Device Description
EpiFaith Syringe is intended for use with an epidural needle for detecting a loss of resistance, which aids a clinician in verifying needle tip placement in the epidural space.
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
- 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
- Yes
- 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 |
|---|---|---|---|---|
| FMF | Syringe, Piston | General Hospital | 880.5860 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44884 | Low-resistance epidural syringe | A low-friction glass or plastic barrel (cylinder) with plunger intended to be used with a needle typically to locate the epidural space. The user advances the needle until a loss of resistance (LOR) is sensed in the plunger, indicating entry into the epidural space. The syringe may then be disconnected to allow the introduction of a catheter through the needle for diagnostic or therapeutic intervention. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 14719875599023 | GS1 | case | 50 | In Commercial Distribution | |
| Primary | 04719875599026 | GS1 | ||||
| Package | 54719875599021 | GS1 | Transport carton | 600 | In Commercial Distribution |
Customer Contacts
- Phone
- +886225672959
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K192421 | 000 |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- 10 – 35 Degrees Celsius
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep away from sunlight