FDA UDI
In Commercial Distribution
🇺🇸 United States
BD Vacutainer® ESR Blood Collection Tubes
DI: 30382903697411
·
Model: 369741
·
BECTON, DICKINSON AND COMPANY
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
100
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Basic Information
- Brand Name
- BD Vacutainer® ESR Blood Collection Tubes
- Primary DI
- 30382903697411
- Version / Model
- 369741
- Catalog Number
- 369741
- Company Name
- BECTON, DICKINSON AND COMPANY
- Labeler DUNS
- 001292192
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 100
- Record Status
- Published
- Publish Date
- 2016-07-28
- Public Version
- 4
- Public Version Date
- 2024-04-12
- Public Version Status
- Update
- Public Device Record Key
- 021d88ac-fbb2-4b14-b16a-f2e23ea9a0b5
Device Description
TUBE ESR GH 13X75 2.4 PLBL BLK
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
- 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
- Yes
- 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 |
|---|---|---|---|---|
| 37558 | Evacuated erythrocyte sedimentation rate (ESR) tube IVD | A sterile glass or plastic tube sealed with a stopper, or other dedicated vessel, containing a pre-measured amount of vacuum and the blood anticoagulant sodium citrate. It is intended to be used alone or in combination with other IVDs (e.g., ESR analyser, scaled measure) for the quantitative determination of the erythrocyte sedimentation rate (ESR) of a whole blood clinical specimen. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 30382903697411 | GS1 | ||||
| Unit of Use | 00382903697410 | GS1 | ||||
| Package | 50382903697415 | GS1 | Case | 10 | In Commercial Distribution |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 4 – 25 Degrees Celsius