FDA UDI
In Commercial Distribution
🇺🇸 United States
Eclipse PRP HC
DI: 00853602008109
·
Model: PRP2000-B
·
ECLIPSE
Product Codes
0
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Eclipse PRP HC
- Primary DI
- 00853602008109
- Version / Model
- PRP2000-B
- Catalog Number
- PRP2000-B
- Company Name
- ECLIPSE
- Labeler DUNS
- 969752364
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-10-04
- Public Version
- 2
- Public Version Date
- 2021-04-07
- Public Version Status
- Update
- Public Device Record Key
- bb51e131-31bb-4a1a-98eb-a8882ab3b0e3
Device Description
Eclipse PRP Blood Draw Kit for 22ml Tubes
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- 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
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58497 | Blood collection set, invasive | A collection of devices intended to be used by a healthcare professional, in combination with evacuated blood collection tubes, for the routine collection of multiple blood specimens from a patient, via one venipuncture, for clinical analyses. It consists of a blood collection needle or venous butterfly/scalp vein needle and additional devices that may include tubing, male/female Luer-lock connectors, clamps, and a blood collection tube holder. Blood access is directly through the vein with the needle. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00853602008109 | GS1 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Weight | 81.3 | Gram | |
| Depth | 1.250 | Inch | |
| Width | 6.438 | Inch | |
| Height | 7.094 | Inch |