Intravia
INTRAVIA Container, 1000 mL Capacity
7manufacturers in China registered for this device type
7catalogue numbers in this listing
8510(k) clearances naming this product code
10recalls on this code
Who Else Makes It
Concentrated in Guangdong (2), Jiangsu (2), Zhejiang (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Ming FAI Industrial (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 17 |
| Yangzhou Xingwei Medical Technology Co., Ltd. | Yangzhou | Jiangsu | Contract manufacturer | 5 |
| Wanying Health & Technology (Zhongshan) Co., Ltd. | Zhongshan | Guangdong | Contract manufacturer | 3 |
| GRI Medical & Electronic Technology Co., Ltd. | Jiaxing | Zhejiang | Contract manufacturer | 71 |
| Ming FAI Enterprise International Co., Ltd. | Kowloon | Hong Kong | Exporter | 18 |
| Yangzhou Weideli Trading Co., Ltd. | Yangzhou | Jiangsu | Contract manufacturer | 10 |
| Beijing L&Z Medical Technology Development Co., Ltd. | Beijing | Beijing | Manufacturer | 2 |
Record
| Listed by | Baxter Healthcare Corporation, United States |
|---|---|
| FDA product code | KPE |
| Device type | Container, I.V. |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5025 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K964853 |
| Record published | 2016-09-24 |
| Record revised | 2024-03-19 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number |
| Storage | Special storage condition: Adhere to storage requirements of added medication. |
| Packaging | Pack of 6, case of 8, case of 6, pack of 8 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 2J8003 | In distribution | |
| 2B8012 | In distribution | |
| 2B8014 | In distribution | |
| 2B8019 | In distribution | |
| 2J8002 | In distribution | |
| 2B8011 | In distribution | |
| 2B8013 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| ChemoPlus | Cardinal Health | 54 |
| Secure® | Metrix Company, THE | 46 |
| EVA TPN Bags | Valmed SRL | 45 |
| ChemoPlus | Cardinal Health 200, LLC | 44 |
| Container, I.V. | Metrix Company, THE | 27 |
| EcoFLX™ Empty Mixing Container | Douglas Medical Products, Inc | 22 |
| Cormix | Metrix Company, THE | 21 |
| PiSA BioPharm | Pisa Biopharm Inc. | 20 |
| Pinnacle® | B. Braun Medical Inc. | 20 |
| Apex® | B. Braun Medical Inc. | 18 |
| Acta Medical | Acta Medical, LLC | 17 |
| McKesson | Mckesson Medical-Surgical Inc. | 14 |
Showing 12 of 59. All products under Container, I.V.
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K111217 | 2011-06-14 |
| K090096 | 2009-01-30 |
| K020485 | 2002-03-12 |
| K983294 | 1998-11-03 |
| K964853 | 1997-03-31 |
| K945193 | 1995-05-12 |
| K932477 | 1994-06-10 |
| K922214 | 1993-03-26 |
Recalls Naming This Product
3 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Baxter Healthcare Corporation | 510(k) number | 2017-07-27 | Class II | Process control | A leak may allow for microbial contamination of the sterile fluid path. | 29,088 units | 2020-11-03 |
| Baxter Healthcare Corporation | 510(k) number | 2014-09-16 | Class I | Equipment maintenance | Particulate matter found inside the fluid path. | 94,224 | 2017-06-21 |
| Baxter Healthcare Corporation | 510(k) number | 2014-09-16 | Class I | Equipment maintenance | Particulate matter found inside the fluid path. | 20448 | 2017-06-21 |
Recalls
5 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2018-09-12 | Class II | Process control | Potential ability to leak once used for compounding. | 158,163 units | 2020-11-02 |
| 2018-09-12 | Class II | Process control | Potential ability to leak once used for compounding. | 281,350 units | 2020-11-02 |
| 2018-09-12 | Class II | Process control | Potential ability to leak once used for compounding. | 110,134 units | 2020-11-02 |
| 2018-09-12 | Class II | Process control | Potential ability to leak once used for compounding. | 136,800 units | 2020-11-02 |
| 2018-09-12 | Class II | Process control | Potential ability to leak once used for compounding. | 456,071 units | 2020-11-02 |
| 2010-02-15 | Not classified | Nonconforming Material/Component | Routine stability testing of the evacuated container product, along with trending of results, indicates that the pH will exceed the upper specification limit prior to the expiration date of this product. | 64,560 units | 2012-01-29 |
| 2010-02-15 | Not classified | Nonconforming Material/Component | Routine stability testing of the evacuated container product, along with trending of results, indicates that the pH will exceed the upper specification limit prior to the expiration date of this product. | 79,308 units | 2012-01-29 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.