Disposable IV Catheters
by Shandong Ande Healthcare Apparatus Co., Ltd. 12 variants
Ref LZZ3318, ZLZ0322, LZZ1224, LZZ1326, LZZ1322, ZLZ0422, ZLZ0520, LZZ1222, ZLZ0224, ZLZ0816, WLZ1718, ZLZ0516, ZLZ2718, WLZ1724, WLZ3820, ZLZ0524, ZLZ0718, ZLZ0526, ZLZ0222, ZLZ0418, ZLZ0318, ZLZ0518, ZLZ0316, ZLZ0522, LZZ1318, ZLZ0514, ZLZ2920, ZLZ0826, ZLZ0220, ZLZ0326, ZLZ2818, ZLZ0814, ZLZ0820, ZLZ0914, ZLZ0314, ZLZ2720, WLZ1826, WLZ1818, ZLZ0218, WLZ1726, 360113133, 360113130, LZZ1218, ZLZ2914, 360113138, ZLZ2820, LZZ1220Model IVC12, IVC13, IVC14, IVC02, IVC06, IVC07, IVC08, IVC09
Active
Valid until
Not listed
FDA recalls
None foundDocuments
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR EUDAMED | Number697044002WLZZCSS7 | Date23 Aug 2024 | StatusActive |
| United States | GUDID listing GUDID | Number16941893139785 | Date8 May 2023 | StatusListed |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- Trade Name
- Disposable IV Catheter
- Generic Name
- Peripheral intravenous cannula
- Device Name
- Disposable IV Catheters
- Model / Reference
- IVC12 EUDAMEDIVC13 EUDAMEDIVC14 EUDAMEDLZZ3318 EUDAMEDZLZ0322 EUDAMEDLZZ1224 EUDAMEDLZZ1326 EUDAMEDLZZ1322 EUDAMEDZLZ0422 EUDAMEDZLZ0520 EUDAMEDLZZ1222 EUDAMEDIVC02 EUDAMEDIVC06 EUDAMEDIVC07 EUDAMEDIVC08 EUDAMEDIVC09 EUDAMEDZLZ0224 EUDAMEDZLZ0816 EUDAMEDWLZ1718 EUDAMEDZLZ0516 EUDAMEDZLZ2718 EUDAMEDWLZ1724 EUDAMEDWLZ3820 EUDAMEDZLZ0524 EUDAMEDZLZ0718 EUDAMEDZLZ0526 EUDAMEDZLZ0222 EUDAMEDZLZ0418 EUDAMEDZLZ0318 EUDAMEDZLZ0518 EUDAMEDZLZ0316 EUDAMEDZLZ0522 EUDAMEDLZZ1318 EUDAMEDZLZ0514 EUDAMEDZLZ2920 EUDAMEDZLZ0826 EUDAMEDZLZ0220 EUDAMEDZLZ0326 EUDAMEDZLZ2818 EUDAMEDZLZ0814 EUDAMEDZLZ0820 EUDAMEDZLZ0914 EUDAMEDZLZ0314 EUDAMEDZLZ2720 EUDAMEDWLZ1826 EUDAMEDWLZ1818 EUDAMEDZLZ0218 EUDAMEDWLZ1726 EUDAMED360113133 EUDAMED360113130 EUDAMEDLZZ1218 EUDAMEDZLZ2914 EUDAMED360113138 EUDAMEDZLZ2820 EUDAMEDLZZ1220 EUDAMEDIVC09-14 GUDID
- Primary DI / UDI-DI
- 16941893139785, 16941512150641, 16941512151297, 16941512151358, 16941512151334, 16941512150719, 16941512150771, 16941512151280, 16941512151761, 16941512150962, 16941512151518, 16941512150757, 16941893139860, 16941512151549, 16941893139839, 16941512150795, 16941512151655, 16941512150801, 16941512151754, 16941512150696, 16941512150627, 16941512150764, 16941512151952, 16941512150788, 16941512151310, 16941512150740, 16941893139853, 16941512151013, 16941512151747, 16941512150665, 16941893139891, 16941512150955, 16941512151693, 16941512151020, 16941512151945, 16941893139877, 16941512151600, 16941512151563, 16941512151730, 16941512151556, 16941893146479, 16941893146455, 16941512152331, 16941512152317, 16941893143003, 16941893146509, 16941893143034, 16941512152324
- Basic UDI-DI
- 697044002WLZZCSS7, 697044002WLZZSCSP, 697044002WLZZSSTP, 697044002WLZZNST8
- 510(k) Number
- FDA Product Code
- FOZ
- EMDN Code
- C01010103, C0101010102, C0101010101, C0101010202, C0101010201
- GMDN Term
- Peripheral intravenous cannula
- Device Class
- Class IIa EUDAMEDClass II GUDID
- Regulation Number
- 880.5200
- EU market of registration
- ItalyFranceAustria
- GUDID distribution status
- In Commercial Distribution
- MRI Safety
- MR Safe
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Model / Reference | IVC12, IVC13, IVC14 LZZ3318 ZLZ0322 LZZ1224 LZZ1326 LZZ1322 ZLZ0422 ZLZ0520 LZZ1222 IVC02, IVC06, IVC07, IVC08, IVC09 ZLZ0224 ZLZ0816 WLZ1718 ZLZ0516 ZLZ2718 WLZ1724 WLZ3820 ZLZ0524 ZLZ0718 ZLZ0526 ZLZ0222 ZLZ0418 ZLZ0318 ZLZ0518 ZLZ0316 ZLZ0522 LZZ1318 ZLZ0514 ZLZ2920 ZLZ0826 ZLZ0220 ZLZ0326 ZLZ2818 ZLZ0814 ZLZ0820 ZLZ0914 ZLZ0314 ZLZ2720 WLZ1826 WLZ1818 ZLZ0218 WLZ1726 360113133 360113130 LZZ1218 ZLZ2914 360113138 ZLZ2820 LZZ1220 | IVC09-14 |
| Device Class | Class IIa | Class II |
Manufacturer details
- EUDAMED SRN
- CN-MF-000011339
- Authorised representative
- MedNet EC-REP GmbH DE-AR-000000002
Other devices from Shandong Ande Healthcare Apparatus Co., Ltd.
See all devices from Shandong Ande Healthcare Apparatus Co., Ltd. →
Properties
Other properties (18)
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Measuring Function: No
- Incorporates Medicinal Product: No
- Prescription Use: No
- Over-the-Counter: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Premarket Exempt: No
- Serial Number: No