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Amxor VacFlush Pre-Filled Normal Saline Flush Syringe
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- Amxor VacFlush Pre-Filled Normal Saline Flush Syringe FDA UDI
- Generic Name
- Irrigation syringe FDA UDI
- Device Name
- AMXOR VASCFLUSH Pre-Filled Normal Saline Syringe is a pre-filled syringe with saline (0.9% sodium chloride injection, NaCl) and are used to help prevent vascular access systems from becoming blocked and to help remove any medication that may be left at the catheter site. FDA UDI
- Model / Reference
- AVF-10 FDA UDI
- Description
- AMXOR VASCFLUSH Pre-Filled Normal Saline Syringe is a pre-filled syringe with saline (0.9% sodium chloride injection, NaCl) and are used to help prevent vascular access systems from becoming blocked and to help remove any medication that may be left at the catheter site. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850049248068 FDA UDI
- 510(k) Number
- K220060 FDA UDI
- FDA Product Code
- NGT FDA UDI
- GMDN Term
- Irrigation syringe 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
Dimensions & Sizes
- Size
- Total Volume — 10 Milliliter FDA UDI
Category: Irrigation syringe
Amxor VacFlush Pre-Filled Normal Saline Flush Syringe by Amxor Healthcare LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Irrigation syringe.
- Centurion — Centurion Medical Products · Class I
- Marina Medical — MARINA MEDICAL INSTRUMENTS, INC. · Class I
- IRRIJET® Single-Use — CooperSurgical, Inc. · Class I
- Dover — Cardinal Health 200, LLC · Class I
- Medline — MEDLINE INDUSTRIES, INC. · Class I
- PROBEVAC — PLASDENT CORP. · Class I
- HSW HENKE-JECT® — Henke-Sass, Wolf GmbH · Class II
- Monoject — Cardinalhealth · Class I
Cleared under the same submission
K220060 also covers:
- 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
- ITL Biomedical — Jiangsu Caina Medical Co., Ltd
- McKesson — MCKESSON MEDICAL-SURGICAL INC.
- McKesson — MCKESSON MEDICAL-SURGICAL INC.
- RELI® — MYCO MEDICAL SUPPLIES INC.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Amxor Healthcare LLC
Sources (1)
- FDA UDI a72b1fe8-164e-456b-adb4-d6d5de09bb81 36 fields · synced Jun 6, 2026