FDA UDI
In Commercial Distribution
🇺🇸 United States
AESCULAP
DI: 14522281506819
·
Model: MD344
·
AESCULAP, INC.
Product Codes
2
GMDN Terms
1
Identifiers
2
Pkg Device Count
1000
Basic Information
- Brand Name
- AESCULAP
- Primary DI
- 14522281506819
- Version / Model
- MD344
- Catalog Number
- MD344
- Company Name
- AESCULAP, INC.
- Labeler DUNS
- 082594540
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1000
- Record Status
- Published
- Publish Date
- 2016-09-22
- Public Version
- 8
- Public Version Date
- 2023-10-18
- Public Version Status
- Update
- Public Device Record Key
- aa356dc7-1f9a-421c-998c-0a59149dff90
Device Description
Disposable Filter, Reusable Filter
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KCT | Sterilization wrap containers, trays, cassettes & other accessories | General Hospital | 880.6850 | 2 |
| FRG | Wrap, sterilization | General Hospital | 880.6850 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60909 | Sterilization container filter, single-use | A device designed to function as a microbial barrier in containers used for steam or solvent sterilization. It allows penetration of the sterilization agent as it prevents the passage of microorganisms. It is typically made of a thin, porous, non-woven fabric material or paper. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 14522281506819 | GS1 | ||||
| Unit of Use | 04522281506812 | GS1 |
Customer Contacts
- Phone
- +1(800)282-9000
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store at controlled room temp