FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Capillary Blood Specimen Collection Supplemental Pack
DI: G292590
·
Model: 6
·
Biodesix, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Capillary Blood Specimen Collection Supplemental Pack
- Primary DI
- G292590
- Version / Model
- 6
- Catalog Number
- 59
- Company Name
- Biodesix, Inc.
- Labeler DUNS
- 809047215
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-07-27
- Public Version
- 6
- Public Version Date
- 2025-09-09
- Public Version Status
- Update
- Public Device Record Key
- 94f4e9f7-1fd2-4125-97ed-8dda8ccbe5c6
- Distribution End Date
- 2025-09-05
Device Description
Capillary blood collection kit, professional
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- 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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| PQD | Blood Specimen Collection Convenience Kit (Excludes Hiv) | Clinical Chemistry | 862.1675 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 65859 | Capillary blood collection set, professional | A collection of devices intended to be used by a healthcare professional at the point-of-care to collect a capillary blood sample from a patient for subsequent diagnostic testing or screening purposes. It typically includes a lancet and a blood collection device (consisting of a capillary tube and blood collection tube) and may also include gloves, gauze pads, alcohol pads and dressings. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | G292590 | HIBCC |