FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Syringe with fixed needle - For use only with GONAL-f Multi-Dose 600 IU/mL FSH
DI: 05413206214167
·
Model: BS-N1A2713U6
·
Terumo Europe NV
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Syringe with fixed needle - For use only with GONAL-f Multi-Dose 600 IU/mL FSH
- Primary DI
- 05413206214167
- Version / Model
- BS-N1A2713U6
- Catalog Number
- BS-N1A2713U6
- Company Name
- Terumo Europe NV
- Labeler DUNS
- 370193559
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-03-15
- Public Version
- 4
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 0af10f76-2e8b-42fa-9d57-da5b8805320b
- Distribution End Date
- 2018-06-19
Device Description
Syringe with fixed needle - For use only with GONAL-f Multi-Dose 600 IU/mL FSH
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 |
|---|---|---|---|---|
| FMF | Syringe, Piston | General Hospital | 880.5860 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35904 | Metered-delivery hypodermic syringe | A sterile device consisting of a graduated barrel (cylinder) with plunger intended to be used to deliver (inject) or withdraw an accurate metered dose of a fluid to/from the body. The application of the content of this device may be in conjunction with an injector device (transcutaneous delivery) or through the traditional use of a needle (subcutaneous delivery). It may allow for retraction of an attached needle (safety syringe); the needle is not 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 | 55413206214162 | GS1 | Carton | 120 | Not in Commercial Distribution | 2018-06-19 |
| Package | 35413206214168 | GS1 | Plastic Box | 6 | Not in Commercial Distribution | 2018-06-19 |
| Primary | 05413206214167 | GS1 |
Customer Contacts
- Phone
- +1(800)283-7866
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K161606 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Syringe Volume: 1 Milliliter | ||
| Device Size Text, specify | Needle Length: 12 Millimeter | ||
| Device Size Text, specify | Needle Outer Diameter: 0.4 Millimeter | ||
| Device Size Text, specify | Needle Length: 0.5 Inch | ||
| Needle Gauge | 27 | Gauge |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Do not store at extreme temperature and humidity.