ITL Biomedical
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- Biomedica EUDAMEDITL Biomedical FDA UDI
- Generic Name
- Vascular catheter/cannula flush solution, non-anticoagulant, non-antimicrobial FDA UDI
- Device Name
- Pre-Filled Syringe with Saline EUDAMEDPrefilled Syringe with Saline 0.9%Sodium Chloride(0.9%NaCl),USP Fully Sterile FDA UDI
- Model / Reference
- PP01 series EUDAMEDJPNCEBM3 EUDAMED3mL FDA UDI
- Description
- Prefilled Syringe with Saline 0.9%Sodium Chloride(0.9%NaCl),USP Fully Sterile FDA UDI
Identifiers
- Catalog Number
- ITL10003 FDA UDI
- Primary DI / UDI-DI
- 46971564464398 EUDAMED06971564464567 FDA UDI
- Basic UDI-DI
- 69715644600340ZU EUDAMED
- 510(k) Number
- K220060 FDA UDI
- FDA Product Code
- NGT FDA UDI
- EMDN Code
- A02010701 PREFILLED SYRINGES WITH STERILE PHYSIOLOGICAL SOLUTION EUDAMED
- GMDN Term
- Vascular catheter/cannula flush solution, non-anticoagulant, non-antimicrobial FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 880.5200 FDA UDI
- Market of Registration
- Austria EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
Yes
Category: Vascular catheter/cannula flush solution, non-anticoagulant, non-antimicrobial
ITL Biomedical by Jiangsu Caina Medical Co., Ltd — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Vascular catheter/cannula flush solution, non-anticoagulant, non-antimicrobial.
- BAL Flush Spritze 10ml DS — Jiaxing Tianhe Pharmaceutical Co., Ltd. · Class IIa
- Pre-fillefd flush syringe(B001-MY) — Jiangsu Embrace Science&Technology Development Co., Ltd. · Class IIa
- Burg Pharma — Jiangsu Caina Medical Co.,Ltd. · Class IIa
- BAL Flush Spritze 5ml SS — Jiaxing Tianhe Pharmaceutical Co., Ltd. · Class IIa
- Pre-Filled Saline Flush Syringe, Sterile, 5mL — Dynarex Corp. · Class II
- Halyard — OWENS & MINOR DISTRIBUTION, INC. · Class II
- EASY FLUSH — SPM MEDICARE PVT, LTD. · Class IIb
- Prefilled Syringe with 0.9% Saline Solution — Poly Medicure Limited · Class IIb
Cleared under the same submission
K220060 also covers:
- Amxor VacFlush Pre-Filled Normal Saline Flush Syringe — Amxor Healthcare LLC
- Pre-Filled Saline Flush Syringe, Sterile, 5mL — Dynarex Corp.
- Pre-Filled Saline Flush Syringes, Sterile, 10mL — Dynarex Corp.
- Prefilled Syrings — GERI-GENTLE CORPORATION
- GBUK — Jiangsu Caina Medical Co., Ltd
- GBUK — Jiangsu Caina Medical Co., Ltd
- GBUK — Jiangsu Caina Medical Co., Ltd
- GBUK — Jiangsu Caina Medical Co., Ltd
- ITL Biomedical — Jiangsu Caina Medical Co., Ltd
- McKesson — MCKESSON MEDICAL-SURGICAL INC.
- McKesson — MCKESSON MEDICAL-SURGICAL INC.
- RELI® — MYCO MEDICAL SUPPLIES INC.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Jiangsu Caina Medical Co., Ltd
Sources (2)
- FDA UDI df9c3f06-bc25-42d8-be14-6845336aa671 35 fields · synced Jul 29, 2026
- EUDAMED 7fc0a095-0cfa-44f4-a6fd-84523d563132 61 fields · synced Jul 29, 2026