FDA UDI
In Commercial Distribution
🇺🇸 United States
NA
DI: 07332414010867
·
Model: 6038020
·
GAMBRO DASCO SPA
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- NA
- Primary DI
- 07332414010867
- Version / Model
- 6038020
- Catalog Number
- 101593
- Company Name
- GAMBRO DASCO SPA
- Labeler DUNS
- 428788780
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-10-28
- Public Version
- 6
- Public Version Date
- 2023-08-10
- Public Version Status
- Update
- Public Device Record Key
- 00beb62a-2520-4345-acf2-c637f4e27b8e
Device Description
SP-C13 Accessory spike
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
- 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 |
|---|---|---|---|---|
| KOC | ACCESSORIES, BLOOD CIRCUIT, HEMODIALYSIS | Gastroenterology, Urology | 876.5820 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 34999 | Haemodialysis blood tubing set, single-use | A collection of tubing segments and associated devices (e.g., connectors, clamps) intended to be used to transfer blood between a patient's vascular access device and a haemodialyser during haemodialysis; it is sometimes referred to as haemodialysis blood lines. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 37332414010868 | GS1 | CASE | 75 | In Commercial Distribution | |
| Primary | 07332414010867 | GS1 |
Customer Contacts
- Phone
- +1(800)933-0303
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 0 – 30 Degrees Celsius
- Type
- Special Storage Condition, Specify
- Special Conditions
- Minimum temperature of use: 20 degrees celsius or 68 degrees fahrenheit
- Type
- Special Storage Condition, Specify
- Special Conditions
- Must be stored in a dry place. Keep dry
- Type
- Storage Environment Temperature
- Temperature Range
- 32 – 86 Degrees Fahrenheit