FDA UDI
In Commercial Distribution
🇺🇸 United States
Patient Safe®
DI: 00613703530004
·
Model: 53001
·
RETRACTABLE TECHNOLOGIES, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
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Basic Information
- Brand Name
- Patient Safe®
- Primary DI
- 00613703530004
- Version / Model
- 53001
- Catalog Number
- 53001
- Company Name
- RETRACTABLE TECHNOLOGIES, INC.
- Labeler DUNS
- 838024255
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-22
- Public Version
- 4
- Public Version Date
- 2018-09-12
- Public Version Status
- Update
- Public Device Record Key
- 8e13837a-91ad-4191-8a02-d398f35a6317
Device Description
30mL Patient Safe® 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
- 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 |
|---|---|---|---|---|
| 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 |
|---|---|---|---|---|---|---|
| Package | 00613703530028 | GS1 | Case | 4 | In Commercial Distribution | |
| Package | 00613703530011 | GS1 | Box | 40 | In Commercial Distribution | |
| Primary | 00613703530004 | GS1 |
Customer Contacts
- Phone
- 888-703-1010
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K072654 | 000 |