FDA UDI
In Commercial Distribution
🇺🇸 United States
BD MiniDraw™ Finger Sleeve, Extra-Large
DI: 50382903666169
·
Model: 366616
·
BECTON, DICKINSON AND COMPANY
Product Codes
2
GMDN Terms
1
Identifiers
3
Pkg Device Count
36
Basic Information
- Brand Name
- BD MiniDraw™ Finger Sleeve, Extra-Large
- Primary DI
- 50382903666169
- Version / Model
- 366616
- Catalog Number
- 366616
- Company Name
- BECTON, DICKINSON AND COMPANY
- Labeler DUNS
- 001292192
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 36
- Record Status
- Published
- Publish Date
- 2024-06-06
- Public Version
- 1
- Public Version Date
- 2024-06-14
- Public Version Status
- New
- Public Device Record Key
- b77a31ea-7e45-4219-a27d-42d64ff33779
Device Description
BD MiniDraw™ Finger Sleeve, Extra-Large
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
- 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
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GIM | Tubes, vacuum sample, with anticoagulant | Clinical Chemistry | 862.1675 | 2 |
| JKA | Tubes, vials, systems, serum separators, blood collection | Clinical Chemistry | 862.1675 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 65883 | Capillary blood collection funnel | A device intended to be used to channel capillary blood from the lancing site on a finger into a blood collection tube. It is a wearable splint-like device placed over the finger with a connector on the distal end, onto which the blood collection tube is attached. The device can also be gently squeezed to massage the finger and encourage blood flow; it can be used by healthcare professionals in clinical settings and by laypersons in the home. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 30382903666165 | GS1 | Shelfpack | 35 | In Commercial Distribution | |
| Primary | 50382903666169 | GS1 | ||||
| Unit of Use | 00382903666164 | GS1 |
Premarket Submissions
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 4 – 25 Degrees Celsius