FDA UDI
In Commercial Distribution
🇺🇸 United States
HEPRO.US 5 ml/cc 23 G x 1 1/2" Single Syringe
DI: 00850578007020
·
Model: SINGLE - 5 ml/cc 23G x 1 1/2"
·
HEPRO.US INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- HEPRO.US 5 ml/cc 23 G x 1 1/2" Single Syringe
- Primary DI
- 00850578007020
- Version / Model
- SINGLE - 5 ml/cc 23G x 1 1/2"
- Company Name
- HEPRO.US INC.
- Labeler DUNS
- 080061451
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-06-20
- Public Version
- 3
- Public Version Date
- 2018-09-12
- Public Version Status
- Update
- Public Device Record Key
- 3889a663-12c8-4d6a-9c30-5d52b0970324
Device Description
HEPRO.US 5 ml/cc 23 G x 1 1/2" Single Syringe
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
- MR Safe
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- Yes
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 |
|---|---|---|---|---|
| 47017 | General-purpose syringe, single-use | A sterile device consisting of a calibrated barrel (cylinder) with plunger intended to be used for injection/withdrawal of fluids/gas (e.g., medication) to/from a medical device or the body (i.e., capable of both); a needle is not included. It is intended for various medical applications and is not dedicated to medication administration. At the distal end of the barrel is a male connector (typically Luer-lock/slip type) for the attachment to a hypodermic needle or an administration set. It is typically made of plastic and silicone materials and may have anti-stick plunger allowing smooth plunger movement, either manually or by a syringe pump. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850578007020 | GS1 |