FDA UDI
In Commercial Distribution
🇺🇸 United States
EXEL 5ML CLEAR HLDR, Non-Sterile
DI: 00020221265316
·
Model: 26531
·
Exel International
Product Codes
2
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- EXEL 5ML CLEAR HLDR, Non-Sterile
- Primary DI
- 00020221265316
- Version / Model
- 26531
- Catalog Number
- 26531
- Company Name
- Exel International
- Labeler DUNS
- 180572216
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-03-16
- Public Version
- 1
- Public Version Date
- 2023-03-24
- Public Version Status
- New
- Public Device Record Key
- 14d4576e-bac5-4522-93a6-76316448eb8d
Device Description
EXEL 5ML CLEAR HLDR, Non-Sterile 1,000PCS/DOUBLE BAG PER CASE
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
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| JKA | Tubes, Vials, Systems, Serum Separators, Blood Collection | Clinical Chemistry | 862.1675 | 2 |
| FMH | Container, Specimen, Sterile | Pathology | 864.3250 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58284 | Blood collection tube holder/needle | A sterile, hand-held cylindrical device with a pre-attached needle designed to be used together with an evacuated blood collection tube to draw blood samples from a patient. It is typically a hollow plastic adaptor with a pre-attached blood collection needle at one end and into which the blood collection tube is inserted at the other end; this also facilitates a multiple-tube blood collection via one venipuncture. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10020221265313 | GS1 | Bag | 1000 | In Commercial Distribution | |
| Primary | 00020221265316 | GS1 | ||||
| Package | 20020221265310 | GS1 | Outer box | 1 | In Commercial Distribution |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 25 Degrees Celsius