FDA UDI
Not in Commercial Distribution
🇺🇸 United States
NA
DI: 00085412476551
·
Model: H93835
·
BAXTER CORPORATION ENGLEWOOD
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- NA
- Primary DI
- 00085412476551
- Version / Model
- H93835
- Catalog Number
- H93835
- Company Name
- BAXTER CORPORATION ENGLEWOOD
- Labeler DUNS
- 078383477
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-23
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 8c2a1c0c-b76f-4396-aaf3-fdcd4cae2978
- Distribution End Date
- 2016-09-25
Device Description
Sterile 0.2 Micron Filter
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
- Yes
- 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 |
|---|---|---|---|---|
| LHI | Set, i.V. Fluid transfer | General Hospital | 880.5440 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 15283 | Laboratory syringe filter | A sterile device used in combination with certain kinds of laboratory syringes to provide filtration of a sample typically for biological molecule isolation (ultrafiltration), removal of particulates, or for the moving phase of a chromatograph (microfiltration). This device typically consists of a membrane sealed within a housing with inlet and outlet connectors. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 50085412476556 | GS1 | CASE | 10 | Not in Commercial Distribution | 2016-09-25 |
| Primary | 00085412476551 | GS1 |
Customer Contacts
- Phone
- +1(800)933-0303
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K900585 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Pore Size | 0.2 | Micrometer |