FDA UDI
Not in Commercial Distribution
🇺🇸 United States
AVANOS
DI: 00193493141708
·
Model: 14170
·
Avanos Medical, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- AVANOS
- Primary DI
- 00193493141708
- Version / Model
- 14170
- Catalog Number
- IMA-20-16
- Company Name
- Avanos Medical, Inc.
- Labeler DUNS
- 079375431
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-03-15
- Public Version
- 2
- Public Version Date
- 2023-03-10
- Public Version Status
- Update
- Public Device Record Key
- 78d06fef-c5e7-473d-9fe1-a6aea33d76ff
- Distribution End Date
- 2022-06-30
Device Description
Analog Manometer
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
- 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 |
|---|---|---|---|---|
| DXT | Injector and syringe, angiographic | Cardiovascular | 870.1650 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 42760 | Buprenorphine IVD, control | A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of buprenorphine in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00193493141708 | GS1 | ||||
| Package | 10193493141705 | GS1 | CS | 5 | Not in Commercial Distribution | 2022-06-30 |
Customer Contacts
- Phone
- +1(844)428-2667
- [email protected]