FDA UDI
In Commercial Distribution
🇺🇸 United States
Medline
DI: 10197344071746
·
Model: DYND10805F
·
MEDLINE INDUSTRIES, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Medline
- Primary DI
- 10197344071746
- Version / Model
- DYND10805F
- Catalog Number
- DYND10805F
- Company Name
- MEDLINE INDUSTRIES, INC.
- Labeler DUNS
- 025460908
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-02-05
- Public Version
- 1
- Public Version Date
- 2024-02-13
- Public Version Status
- New
- Public Device Record Key
- e4abcf60-d708-4cf7-a258-de2de45440e8
Device Description
KIT,FIRM SPECI-CATH,FEM,8FR 6.5
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
- 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 |
|---|---|---|---|---|
| EZD | Catheter, straight | Gastroenterology, Urology | 876.5130 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 65289 | Biological fluid specimen capillary collector IVD | A sampling receptacle in the form of small plastic tube with a thin pointed tip intended to be used to collect any type of biological fluid specimen (e.g., tears, saliva, sweat, urine) from a patient’s body via capillary action. It is designed to be placed on the target fluid whereby the fluid is drawn into the vessel for its collection, containment, preservation and/or transportation for subsequent culture, analysis, and/or other investigation. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20197344071743 | GS1 | CS | 25 | In Commercial Distribution | |
| Primary | 10197344071746 | GS1 |
Customer Contacts
- Phone
- +1(800)633-5463
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Protect from frezzing and excessive heat. Shield froom direct sunlight.