Identity
- Trade Name
- GBUK FDA UDI
- Generic Name
- Vascular catheter/cannula flush solution, non-anticoagulant, non-antimicrobial FDA UDI
- Device Name
- 10 ml XS Prefilled saline syringe 0.9%Sodium Chloride(0.9% Na Cl), USP FDA UDI
- Model / Reference
- 10mL FDA UDI
- Description
- 10 ml XS Prefilled saline syringe 0.9%Sodium Chloride(0.9% Na Cl), USP FDA UDI
Identifiers
- Catalog Number
- PFS-10DSU FDA UDI
- Primary DI / UDI-DI
- 06971564461108 FDA UDI
- 510(k) Number
- K220060 FDA UDI
- FDA Product Code
- NGT FDA UDI
- GMDN Term
- Vascular catheter/cannula flush solution, non-anticoagulant, non-antimicrobial FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5200 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Vascular catheter/cannula flush solution, non-anticoagulant, non-antimicrobial
Gbuk by Jiangsu Caina Medical Co., Ltd — Class II — MDD, 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
- ITL Biomedical — 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
European Union Unknown
MDD
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Jiangsu Caina Medical Co., Ltd
Sources (2)
- FDA UDI 8c3dcff2-e1d4-4348-991a-bfe6450c22c1 35 fields · synced Jun 20, 2026
- EUDAMED 1 fields · synced Jun 2, 2026