FDA UDI
In Commercial Distribution
🇺🇸 United States
EXTENSION SET
DI: 00085412639321
·
Model: 2N3356
·
BAXTER HEALTHCARE CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- EXTENSION SET
- Primary DI
- 00085412639321
- Version / Model
- 2N3356
- Catalog Number
- 2N3356
- Company Name
- BAXTER HEALTHCARE CORPORATION
- Labeler DUNS
- 005083209
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-10-21
- Public Version
- 1
- Public Version Date
- 2020-10-29
- Public Version Status
- New
- Public Device Record Key
- b861b07f-7b74-4ca7-aa51-1f312d5dd95c
Device Description
Mini-Volume Extension Set
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
- Yes
- 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 | 50085412639326 | GS1 | CASE | 50 | In Commercial Distribution | |
| Primary | 00085412639321 | GS1 |
Customer Contacts
- Phone
- +1(800)933-0303
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K192366 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 2000000000000000 | Femtometer | |
| Pressure | 45 | Pound per Square Inch | |
| Total Volume | 1.1 | Milliliter |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store at Room Temperature, Keep dry, keep away from sunglight (or heat)