FDA UDI
In Commercial Distribution
🇺🇸 United States
BD Vacutainer® CPT™ Cell Preparation Tube with Sodium Citrate
DI: 30382903627616
·
Model: 362761
·
BECTON, DICKINSON AND COMPANY
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
60
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Basic Information
- Brand Name
- BD Vacutainer® CPT™ Cell Preparation Tube with Sodium Citrate
- Primary DI
- 30382903627616
- Version / Model
- 362761
- Catalog Number
- 362761
- Company Name
- BECTON, DICKINSON AND COMPANY
- Labeler DUNS
- 001292192
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 60
- Record Status
- Published
- Publish Date
- 2016-08-22
- Public Version
- 6
- Public Version Date
- 2024-06-12
- Public Version Status
- Update
- Public Device Record Key
- 0c54884a-1aa0-4672-a44b-ed789d3f34f2
Device Description
TUBE CPTCIT GC 16X125 8.0 MLBL BL/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 |
|---|---|---|---|---|
| JCF | LYMPHOCYTE SEPARATION MEDIUM | Hematology | 864.8500 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 65457 | Evacuated blood collection tube IVD, anticoagulant/separator/density solution | A glass or plastic tube, sealed with a stopper, containing a pre-measured amount of vacuum, an anticoagulant [e.g., ethylenediaminetetraacetic acid (EDTA), sodium heparin, sodium citrate, potassium oxalate], a separator (e.g., gel or elastomer) to separate plasma from bloods cells, and density solution to isolate plasma and mononuclear cells from other whole blood components. It is intended to be used for the collection, and preservation and/or transport, of blood for analysis and/or other investigation (e.g., mononuclear cell analysis, plasma chemistry determinations). Additional blood freezing tubes (cryovials) may be supplied with the device. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 30382903627616 | GS1 | ||||
| Unit of Use | 00382903627615 | GS1 | ||||
| Package | 50382903627610 | GS1 | Case | 1 | In Commercial Distribution |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 18 – 25 Degrees Celsius