FDA UDI
Not in Commercial Distribution
🇺🇸 United States
BD Seditainer™ Stand
DI: 00382903660162
·
Model: 366016
·
Becton, Dickinson U.K. Limited
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- BD Seditainer™ Stand
- Primary DI
- 00382903660162
- Version / Model
- 366016
- Catalog Number
- 366016
- Company Name
- Becton, Dickinson U.K. Limited
- Labeler DUNS
- 225931062
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-04-18
- Public Version
- 2
- Public Version Date
- 2025-02-04
- Public Version Status
- Update
- Public Device Record Key
- dee5c963-ba75-4c54-a8f1-d1d0eaecac86
- Distribution End Date
- 2025-01-28
Device Description
ESR SEDITAINER TUBE STAND FOR 10 TUBES
Device Characteristics
- Single Use
- No
- 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
- No
- 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 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58170 | Erythrocyte sedimentation rate (ESR) rack IVD, scaled measure | A dedicated, non-sterile, rack with a build-in graduated scale ruler, with or without a programmable timer or stop-clock, intended to be used to hold erythrocyte sedimentation rate (ESR) tubes containing unmarked columns of blood in an upright and secured position, as required when performing a manual estimation of the ESR of a whole blood clinical specimen. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00382903660162 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K953994 | 000 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Room Temperature