FDA UDI
In Commercial Distribution
🇺🇸 United States
MaxGuard
DI: 10885403274435
·
Model: ME5303
·
BD Switzerland Sàrl
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
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Basic Information
- Brand Name
- MaxGuard
- Primary DI
- 10885403274435
- Version / Model
- ME5303
- Catalog Number
- ME5303
- Company Name
- BD Switzerland Sàrl
- Labeler DUNS
- 482631558
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-22
- Public Version
- 6
- Public Version Date
- 2025-11-14
- Public Version Status
- Update
- Public Device Record Key
- 16b75f14-71a5-498e-a70a-59c164565183
Device Description
Pressure rated extension set, 19 cm (7.5 in)
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 |
|---|---|---|---|---|
| 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 | 20885403274432 | GS1 | Case | 12 | In Commercial Distribution | |
| Primary | 10885403274435 | GS1 | ||||
| Package | 50885403274433 | GS1 | Pack or Inner Pack | 50 | In Commercial Distribution |
Customer Contacts
- Phone
- +1(844)823-5433
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Total Volume | 0.4 | Milliliter | |
| Device Size Text, specify | Flow Rate = 10 millilitre per second (mL/s) | ||
| Length | 7.5 | Inch |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep away from sunlight
- Type
- Special Storage Condition, Specify
- Special Conditions
- Fragile, handle with care
- Type
- Storage Environment Temperature
- Temperature Range
- -40 – 125 Degrees Fahrenheit
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep dry