FDA UDI
In Commercial Distribution
🇺🇸 United States
CarePoint Precision
DI: 00786227221557
·
Model: 303-2158
·
ALLISON MEDICAL, INC.
Product Codes
2
GMDN Terms
1
Identifiers
3
Pkg Device Count
100
Basic Information
- Brand Name
- CarePoint Precision
- Primary DI
- 00786227221557
- Version / Model
- 303-2158
- Company Name
- ALLISON MEDICAL, INC.
- Labeler DUNS
- 825097264
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 100
- Record Status
- Published
- Publish Date
- 2023-11-29
- Public Version
- 1
- Public Version Date
- 2023-12-07
- Public Version Status
- New
- Public Device Record Key
- b6c049ff-8b5f-4efa-9e5c-edc9ae61e0e4
Device Description
1ml Luer Slip TB with 25G x 5/8" Needle
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
- 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
- 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 |
|---|---|---|---|---|
| FMI | Needle, Hypodermic, Single Lumen | General Hospital | 880.5570 | 2 |
| FMF | Syringe, Piston | General Hospital | 880.5860 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63095 | General-purpose syringe/needle | 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 non-retractable needle is included, either attached or detached (usually capped for user protection). It is intended for various medical applications and is not dedicated to medication administration. The syringe 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 | 00786227221571 | GS1 | Case | 36 | In Commercial Distribution | |
| Primary | 00786227221557 | GS1 | ||||
| Unit of Use | 00786227221519 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K124037 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Needle Gauge | 25 | Gauge | |
| Length | 0.625 | Inch | |
| Total Volume | 1 | Milliliter |