FDA UDI
In Commercial Distribution
🇺🇸 United States
WalkMed®
DI: 00859695006008
·
Model: 202659
·
Walkmed Infusion LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- WalkMed®
- Primary DI
- 00859695006008
- Version / Model
- 202659
- Catalog Number
- PS400/300
- Company Name
- Walkmed Infusion LLC
- Labeler DUNS
- 948594726
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- d4b121b4-dc5e-457f-ae1a-502456f8945d
Device Description
Pump Tubing Set for WalkMed Infusion Pump, 101 cm
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 |
|---|---|---|---|---|
| 35833 | Electric infusion pump administration set, single-use | A collection of sterile devices (e.g., plastic tubing, check valve, roller clamp, Y-site connector, Luer, needle/catheter) intended to be used in combination with an electrically-powered infusion pump for the intravenous (IV), subcutaneous, intramuscular, or epidural administration of medication. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10859695006005 | GS1 | Case Package of 10 | 10 | In Commercial Distribution | |
| Primary | 00859695006008 | GS1 |
Customer Contacts
- Phone
- 303-420-9569
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 101 | Centimeter |
Storage Conditions
- Type
- Storage Environment Humidity
- Temperature Range
- – 90 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- -34.4 – 54.4 Degrees Celsius