FDA UDI
In Commercial Distribution
🇺🇸 United States
PVC Hydrophilic Urethral Catheter
DI: 06971976786783
·
Model: H01-18M
·
Chengdu Daxan Innovative Medical Tech. Co., Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
30
Basic Information
- Brand Name
- PVC Hydrophilic Urethral Catheter
- Primary DI
- 06971976786783
- Version / Model
- H01-18M
- Company Name
- Chengdu Daxan Innovative Medical Tech. Co., Ltd.
- Labeler DUNS
- 554453716
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 30
- Record Status
- Published
- Publish Date
- 2023-09-26
- Public Version
- 1
- Public Version Date
- 2023-10-04
- Public Version Status
- New
- Public Device Record Key
- 2a078463-dd9d-4f0f-8464-bd71106bdc45
Device Description
Man normal type,Catheter OD.18Fr
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 |
|---|---|---|---|---|
| EZD | Catheter, Straight | Gastroenterology, Urology | 876.5130 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64266 | Intermittent urethral drainage catheter, non-antimicrobial, single-use | A flexible or rigid tube designed for a single insertion into the urethra, typically by the user (i.e., self-applied), to the urinary bladder to provide urine drainage, typically for an individual who is physiologically incapable of voiding. The device is typically pre-lubricated or coated with/made of materials that facilitate easy insertion and removal [e.g., polytetrafluoroethylene (PTFT) - Teflon, or glass] and is disposed of after use; it does not include an antimicrobial agent(s). The device may be male or female dedicated. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 86971976786789 | GS1 | ||||
| Primary | 06971976786783 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K212567 | 000 |