FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Bone Marrow Collection Kit with Flexible Pre-Filter and Inline Filters
DI: 04086000100366
·
Model: X6R2107
·
Fresenius Kabi AG
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Bone Marrow Collection Kit with Flexible Pre-Filter and Inline Filters
- Primary DI
- 04086000100366
- Version / Model
- X6R2107
- Catalog Number
- X6R2107
- Company Name
- Fresenius Kabi AG
- Labeler DUNS
- 315654579
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-05
- Public Version
- 3
- Public Version Date
- 2024-07-15
- Public Version Status
- Update
- Public Device Record Key
- 2a2ddeae-a305-4526-b790-46c01590788a
- Distribution End Date
- 2020-12-31
Device Description
For Collection and Filtration of up to 1.2 Liters of Aspirated Bone Marrow. Must be used with the Bone Marrow Collection Stand.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- Yes
- 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
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LWE | Bone Marrow Collection/Transfusion Kit | Unknown | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 33984 | Bone marrow collection/transfusion set | A sterile collection of instruments, pharmaceuticals, and other items intended for use in combination to collect and/or deliver bone marrow. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04086000100366 | GS1 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store at Room Temperature. Protect from freezing. Avoid excessive heat.