FDA UDI
In Commercial Distribution
🇺🇸 United States
HEPRO.US - Tuberculin Syringe attached needle, 1ml/cc 25G x 5/8"
DI: 00850578007365
·
Model: BX Tuberculin Syringe 1ml/cc 25G x 5/8"
·
HEPRO.US INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
100
Basic Information
- Brand Name
- HEPRO.US - Tuberculin Syringe attached needle, 1ml/cc 25G x 5/8"
- Primary DI
- 00850578007365
- Version / Model
- BX Tuberculin Syringe 1ml/cc 25G x 5/8"
- Company Name
- HEPRO.US INC.
- Labeler DUNS
- 080061451
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 100
- Record Status
- Published
- Publish Date
- 2017-06-21
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- fb453b1c-b08c-49cf-bd8a-be926113cd8f
Device Description
Tuberculin Syringe permanently attached needle, 1ml/cc 25G x 5/8", 10 pcs per Bag, 10 Bags per Box
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 |
|---|---|---|---|---|
| 32592 | Tuberculin/allergy syringe/needle, safety | A sterile device consisting of a calibrated barrel (cylinder) with plunger, with an attached needle (sometimes shielded), intended to be used to administer a precise, low-dosage injection of tuberculin and/or sensitivity test allergen to a patient subcutaneously. The syringe is typically made of plastic and silicone materials and will have plunger anti-sticking properties allowing smooth plunger movement. It can be used by healthcare personnel or patients. After use, the needle can be fully retracted into the barrel, providing protection against needle sticks and rendering the device unusable. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850578007365 | GS1 | ||||
| Unit of Use | 85057800736501 | GS1 |