FDA UDI
In Commercial Distribution
🇺🇸 United States
MEDLINE
DI: 10888277733299
·
Model: DYNDH1035E
·
MEDLINE INDUSTRIES, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- MEDLINE
- Primary DI
- 10888277733299
- Version / Model
- DYNDH1035E
- Catalog Number
- DYNDH1035E
- Company Name
- MEDLINE INDUSTRIES, INC.
- Labeler DUNS
- 025460908
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-05-08
- Public Version
- 1
- Public Version Date
- 2020-05-18
- Public Version Status
- New
- Public Device Record Key
- 8b61814d-ab42-44dc-9a2b-a1ad12f8e826
Device Description
DIALYSIS OFF KIT
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- Yes
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- Yes
- PM Exempt
- Yes
- 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 |
|---|---|---|---|---|
| FKG | TRAY, START/STOP (INCLUDING CONTENTS), DIALYSIS | Gastroenterology, Urology | 876.5820 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 32142 | Haemodialysis start/stop set | A collection of instruments and associated items used for the start and/or stop procedures (also known as ON and OFF procedures) for a patient undergoing haemodialysis. It typically includes items such as syringes, needles, dressings, swabs, forceps, and protective wear for the healthcare provider such as gloves, face mask, and a gown. This device is used for the connection session and/or the disconnection session where the patient is connected/disconnected to the haemodialysis system. It does not include pharmaceuticals and typically does not include catheters. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20888277733296 | GS1 | CASE | 20 | In Commercial Distribution | |
| Primary | 10888277733299 | GS1 |
Customer Contacts
- Phone
- +1(800)633-5463
- [email protected]