FDA UDI
In Commercial Distribution
🇺🇸 United States
MaxGuard, MaxPlus
DI: 50885403236752
·
Model: MP9002
·
CAREFUSION 303, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
50
Basic Information
- Brand Name
- MaxGuard, MaxPlus
- Primary DI
- 50885403236752
- Version / Model
- MP9002
- Catalog Number
- MP9002
- Company Name
- CAREFUSION 303, INC.
- Labeler DUNS
- 360624720
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 50
- Record Status
- Published
- Publish Date
- 2016-09-22
- Public Version
- 4
- Public Version Date
- 2020-04-27
- Public Version Status
- Update
- Public Device Record Key
- 8bfa6c92-2c50-4227-83be-ad345e7f35de
Device Description
MaxGuard multi-fuse extension set with needleless connector (s)
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 |
|---|---|---|---|---|
| FPA | Set, administration, intravascular | General Hospital | 880.5440 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 12170 | Intravenous administration tubing extension set | A collection of tubing and connectors intended to establish an extension of tubing where the standard length of the tubing in an intravenous (IV) administration set is insufficient. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20885403236751 | GS1 | Box | 12 | In Commercial Distribution | |
| Primary | 50885403236752 | GS1 | ||||
| Unit of Use | 10885403236754 | GS1 |
Customer Contacts
- Phone
- +1(800)854-7128
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -40 – 125 Degrees Fahrenheit