FDA UDI
In Commercial Distribution
🇺🇸 United States
Medline
DI: 10080196998401
·
Model: DYND17403
·
MEDLINE INDUSTRIES, INC.
Product Codes
2
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Medline
- Primary DI
- 10080196998401
- Version / Model
- DYND17403
- Catalog Number
- DYND17403
- Company Name
- MEDLINE INDUSTRIES, INC.
- Labeler DUNS
- 025460908
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-12-23
- Public Version
- 1
- Public Version Date
- 2020-12-31
- Public Version Status
- New
- Public Device Record Key
- 0664e0ad-47e8-46b1-9350-1ccf7ed07a74
Device Description
METER,URINE,DRAIN BAG,400 ML,LF
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
- 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 |
|---|---|---|---|---|
| FFG | DEVICE, URINE FLOW RATE MEASURING, NON-ELECTRICAL, DISPOSABLE | Gastroenterology, Urology | 876.1800 | 2 |
| FON | BAG, DRAINAGE, WITH ADHESIVE, OSTOMY | Gastroenterology, Urology | 876.5900 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 32072 | Urine flowmeter, single-use | A non-electrical device that is used to measure the volume or flow of urine from a patient, either during the course of normal urination or while the patient is catheterized. The device may include a drip chamber to reduce the risk of retrograde bacterial contamination of the bladder. This device is a single-use device. This GMDN code may reflect old technology. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 40080196998402 | GS1 | 10 | In Commercial Distribution | ||
| Primary | 10080196998401 | GS1 |
Customer Contacts
- Phone
- +1(800)633-5463
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Label does not mention Storage Conditions