FDA UDI
In Commercial Distribution
🇺🇸 United States
ASP POD
DI: 10860008222418
·
Model: A-03
·
ASP Health Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- ASP POD
- Primary DI
- 10860008222418
- Version / Model
- A-03
- Catalog Number
- PI-0077055
- Company Name
- ASP Health Inc.
- Labeler DUNS
- 050200201
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-04-05
- Public Version
- 1
- Public Version Date
- 2024-04-15
- Public Version Status
- New
- Public Device Record Key
- 7b283861-0ed5-48f4-8944-32aef67876bc
Device Description
The ASP POD is intended to be used only with the ASP Device, ASP System, and ROSE Prep Pro - DI number: 00860008222404. The ASP POD is used to hold the sample that is to be deposited onto the slide.
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
- 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 |
|---|---|---|---|---|
| KPA | Slide Stainer, Automated | Pathology | 864.3800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 15599 | Microscope slide stainer IVD | An automated mains electricity (AC-powered) laboratory instrument intended to be used to stain blood, tissue and/or other clinical specimens fixed to microscope examination slides, using one or more biological or cytochemical staining solutions in preparation for subsequent microscopic analysis. The device operates with minimal technician involvement and complete automation of all procedural steps. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20860008222415 | GS1 | Multipack | 480 | In Commercial Distribution | |
| Primary | 10860008222418 | GS1 |
Customer Contacts
- Phone
- 877-527-7432
- [email protected]
Storage Conditions
- Type
- Handling Environment Humidity
- Temperature Range
- 20 – 80 Percent (%) Relative Humidity
- Type
- Storage Environment Humidity
- Temperature Range
- 20 – 80 Percent (%) Relative Humidity
- Type
- Handling Environment Temperature
- Temperature Range
- -20 – 50 Degrees Celsius
- Type
- Storage Environment Temperature
- Temperature Range
- -20 – 50 Degrees Celsius