FDA UDI
In Commercial Distribution
🇺🇸 United States
Advocate Syringes for U-100 Insulin 30G .3CC 5/16" Needle
DI: 00894046001806
·
Model: 607
·
DIABETIC SUPPLY OF SUNCOAST, INC.
Product Codes
1
GMDN Terms
1
Identifiers
4
Pkg Device Count
10
Basic Information
- Brand Name
- Advocate Syringes for U-100 Insulin 30G .3CC 5/16" Needle
- Primary DI
- 00894046001806
- Version / Model
- 607
- Catalog Number
- 607S
- Company Name
- DIABETIC SUPPLY OF SUNCOAST, INC.
- Labeler DUNS
- 043081723
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 10
- Record Status
- Published
- Publish Date
- 2016-08-20
- Public Version
- 7
- Public Version Date
- 2022-02-07
- Public Version Status
- Update
- Public Device Record Key
- 2fc5363b-53fc-41be-9ce0-574f284f8309
Device Description
Advocate Syringes for U-100 Insulin 30G .3CC 5/16" Needle, Single Use, Sleeve of 10
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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 |
|---|---|---|---|---|---|---|
| Primary | 00894046001806 | GS1 | ||||
| Package | 00894046001660 | GS1 | 608 | 10 | In Commercial Distribution | |
| Unit of Use | 00894046001998 | GS1 | ||||
| Package | 10894046001667 | GS1 | 628 | 50 | In Commercial Distribution |
Customer Contacts
- Phone
- 8884693579
- [email protected]