FDA UDI
In Commercial Distribution
🇺🇸 United States
DxH
DI: 15099590209636
·
Model: B01276
·
Beckman Coulter, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
20
Basic Information
- Brand Name
- DxH
- Primary DI
- 15099590209636
- Version / Model
- B01276
- Catalog Number
- B01276
- Company Name
- Beckman Coulter, Inc.
- Labeler DUNS
- 008254708
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 20
- Record Status
- Published
- Publish Date
- 2024-11-11
- Public Version
- 1
- Public Version Date
- 2024-11-19
- Public Version Status
- New
- Public Device Record Key
- e528114f-02fd-4385-983f-978e1ed77669
Device Description
Beckman Coulter DxH Slides are microscopic slides intended to be used to prepare whole blood samples for histological stains and preservation of blood for microscopic evaluation. Beckman Coulter DxH Slides are 25 x 75 x 1 mm glass microscope slides with white or painted frosted ends. Beckman Coulter DxH Slides are used with the DxH Slidemaker Stainers, fully automated slide preparation and staining devices that smear a blood film on a clean microscope slide, and deliver a variety of fixatives, stains, buffers, and rinse solutions to the blood smear on the slide.
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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| LXG | Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use | Clinical Chemistry | 862.2050 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 57925 | General specimen microscopy slide IVD, single-use | A glass or plastic microscopy slide intended to be used for the collection, and preservation and/or transport, of any type of clinical specimen or smear for analysis and/or other investigation. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 15099590209636 | GS1 | ||||
| Unit of Use | 05099590209639 | GS1 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 30 Degrees Celsius
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep Dry