Arrow
Maximal Barrier Precautions for High Volume Infusions. Two-Lumen Hemodialysis Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue(R) Curved Catheter, Sharps Safety Features, and…
Maximal Barrier Precautions for High Volume Infusions. Two-Lumen Hemodialysis Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue(R) Curved Catheter, Sharps Safety Features, and Maximal Barrier Precautions for High Volume Infus
1manufacturer
376catalogue numbers in this listing
Who Else Makes It
Registered in Guangdong.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Guangdong Baihe Medical Technology Co., Ltd. | Foshan | Guangdong | Contract manufacturer | 4 |
Record
| Listed by | Teleflex Medical LLC, United States |
|---|---|
| FDA product code | MPB |
| Device type | Catheter, Hemodialysis, Non-Implanted |
| Device class | Class 2 |
| Regulation | 21 CFR 876.5540 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K993933 |
| Record published | 2018-12-14 |
| Record revised | 2023-02-06 (version 22) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Ethylene Oxide |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Storage environment temperature 20 to 25 °C |
| Packaging | Case of 5, multipack of 5, case of 3, case, box of 25 |
| Sizes | Catheter gauge 8 to 14 Fr; length 11 to 25 cm |
| Distribution end date | 2025-09-12 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| IPN036972 | In distribution | |
| IPN030113 | Length 15 cm | In distribution |
| IPN030101 | Catheter Gauge 14 Fr | In distribution |
| IPN030114 | In distribution | |
| IPN036723 | In distribution | |
| IPN030157 | Length 20 cm | In distribution |
| IPN927348 | In distribution | |
| IPN030098 | Catheter Gauge 14 Fr | In distribution |
| IPN927338 | In distribution | |
| IPN030873 | Catheter Gauge 12 Fr | In distribution |
| IPN030171 | In distribution | |
| IPN032911 | Catheter Gauge 12 Fr | In distribution |
| IPN030208 | Length 16 cm | In distribution |
| IPN930618 | In distribution | |
| IPN036960 | In distribution | |
| IPN030101 | Length 20 cm | In distribution |
| IPN030211 | Catheter Gauge 12 Fr | In distribution |
| IPN931143 | Catheter Gauge 14 Fr | In distribution |
| IPN030257 | Length 16 cm | In distribution |
| IPN036724 | In distribution | |
| IPN033193 | Length 20 cm | In distribution |
| IPN036960 | In distribution | |
| IPN030173 | Length 25 cm | In distribution |
| IPN030153 | In distribution | |
| IPN035478 | Length 16 cm | In distribution |
| IPN033968 | In distribution | |
| IPN030172 | Catheter Gauge 14 Fr | In distribution |
| IPN036967 | In distribution | |
| IPN030071 | Catheter Gauge 14 Fr | In distribution |
| IPN038095 | In distribution | |
| IPN904933 | In distribution | |
| IPN036419 | In distribution | |
| IPN037802 | In distribution | |
| IPN038336 | In distribution | |
| IPN030147 | In distribution | |
| IPN030204 | In distribution | |
| IPN030100 | Length 20 cm | In distribution |
| IPN030883 | Length 20 cm | In distribution |
| IPN032972 | Length 13 cm | In distribution |
| IPN030257 | Length 16 cm | In distribution |
| IPN036412 | In distribution | |
| IPN030216 | In distribution | |
| IPN033989 | Length 20 cm | In distribution |
| IPN036971 | In distribution | |
| IPN030214 | Catheter Gauge 12 Fr | In distribution |
| IPN033968 | In distribution | |
| IPN033987 | In distribution | |
| IPN033989 | Catheter Gauge 12 Fr | In distribution |
| IPN036973 | In distribution | |
| IPN036960 | In distribution | |
| IPN030851 | In distribution | |
| IPN030073 | Catheter Gauge 14 Fr | In distribution |
| IPN030070 | Catheter Gauge 14 Fr | In distribution |
| IPN030072 | In distribution | |
| IPN033100 | Catheter Gauge 12 Fr | In distribution |
| IPN035509 | Catheter Gauge 12 Fr | In distribution |
| IPN036974 | In distribution | |
| IPN030871 | Length 13 cm | In distribution |
| IPN030148 | Length 20 cm | In distribution |
| IPN919689 | In distribution | |
| IPN035480 | Catheter Gauge 12 Fr | In distribution |
| IPN030207 | In distribution | |
| IPN033994 | Length 20 cm | In distribution |
| IPN033987 | Catheter Gauge 12 Fr | In distribution |
| IPN036959 | In distribution | |
| IPN036419 | In distribution | |
| IPN931142 | In distribution | |
| IPN030849 | Length 16 cm | In distribution |
| IPN036975 | In distribution | |
| IPN036717 | In distribution | |
| IPN036719 | In distribution | |
| IPN033202 | Catheter Gauge 12 Fr | In distribution |
| IPN038096 | In distribution | |
| IPN033968 | Length 15 cm | In distribution |
| IPN919767 | In distribution | |
| IPN030112 | Length 15 cm | In distribution |
| IPN036720 | In distribution | |
| IPN035484 | Catheter Gauge 14 Fr | In distribution |
| IPN919765 | In distribution | |
| IPN033962 | In distribution | |
| IPN035485 | In distribution | |
| IPN033099 | Catheter Gauge 12 Fr | In distribution |
| IPN036959 | In distribution | |
| IPN030148 | Catheter Gauge 12 Fr | In distribution |
| IPN919419 | In distribution | |
| IPN035358 | Catheter Gauge 12 Fr | In distribution |
| IPN032923 | Length 20 cm | In distribution |
| IPN035507 | Catheter Gauge 12 Fr | In distribution |
| IPN036971 | In distribution | |
| IPN036961 | In distribution | |
| IPN032924 | Catheter Gauge 12 Fr | In distribution |
| IPN030173 | Catheter Gauge 14 Fr | In distribution |
| IPN036723 | In distribution | |
| IPN037801 | In distribution | |
| IPN033194 | Catheter Gauge 12 Fr | In distribution |
| IPN919795 | In distribution | |
| IPN030060 | In distribution | |
| IPN036719 | In distribution | |
| IPN036964 | In distribution | |
| IPN035480 | In distribution | |
| IPN036975 | In distribution | |
| IPN036967 | In distribution | |
| IPN036972 | In distribution | |
| IPN927359 | In distribution | |
| IPN030154 | Catheter Gauge 14 Fr | In distribution |
| IPN036973 | In distribution | |
| IPNB00335 | In distribution | |
| IPN030154 | Catheter Gauge 14 Fr | In distribution |
| IPN036722 | In distribution | |
| IPN036944 | In distribution | |
| IPN030883 | Length 20 cm | In distribution |
| IPN033099 | Length 25 cm | In distribution |
| IPN030065 | Length 20 cm | In distribution |
| IPN038320 | In distribution | |
| IPN030209 | Length 16 cm | In distribution |
| IPN033994 | Catheter Gauge 14 Fr | In distribution |
| IPN035357 | Length 13 cm | In distribution |
| IPN030149 | Catheter Gauge 12 Fr | In distribution |
| IPN035503 | Catheter Gauge 14 Fr | In distribution |
| IPN030157 | Length 20 cm | In distribution |
| IPN033905 | Catheter Gauge 8 Fr | In distribution |
| IPN036958 | In distribution | |
| IPN030156 | In distribution | |
| IPN036975 | In distribution | |
| IPN036428 | In distribution | |
| IPN036718 | In distribution | |
| IPN036428 | In distribution | |
| IPN038489 | In distribution | |
| IPN030060 | In distribution | |
| IPN030208 | Catheter Gauge 12 Fr | In distribution |
| IPN033100 | Length 25 cm | In distribution |
| IPN036964 | In distribution | |
| IPN036960 | In distribution | |
| IPN030851 | In distribution | |
| IPN055554 | In distribution | |
| IPN035356 | Catheter Gauge 12 Fr | In distribution |
| IPN035357 | Length 13 cm | In distribution |
| IPN033967 | Length 15 cm | In distribution |
| IPN034794 | In distribution | |
| IPN037800 | In distribution | |
| IPN032973 | Length 20 cm | In distribution |
| IPN919799 | In distribution | |
| IPN030218 | Catheter Gauge 12 Fr | In distribution |
| IPN030107 | Length 16 cm | In distribution |
| IPN030115 | Catheter Gauge 14 Fr | In distribution |
| IPN036726 | In distribution | |
| IPN033910 | Length 15 cm | In distribution |
| IPN036959 | In distribution | |
| IPN036970 | In distribution | |
| IPN036721 | In distribution | |
| IPN030659 | In distribution | |
| IPN035478 | Catheter Gauge 12 Fr | In distribution |
| IPN033960 | Length 16 cm | In distribution |
| IPN030155 | Length 20 cm | In distribution |
| IPN033194 | Catheter Gauge 12 Fr | In distribution |
| IPN030256 | Length 16 cm | In distribution |
| IPN032923 | Catheter Gauge 12 Fr | In distribution |
| IPN919783 | In distribution | |
| IPN036961 | In distribution | |
| IPN927345 | In distribution | |
| IPN038327 | In distribution | |
| IPN036716 | In distribution | |
| IPN927357 | In distribution | |
| IPN927339 | In distribution | |
| IPN035501 | Length 20 cm | In distribution |
| IPN036725 | In distribution | |
| IPN919945 | In distribution | |
| IPN035503 | Catheter Gauge 14 Fr | In distribution |
| IPN035509 | Catheter Gauge 12 Fr | In distribution |
| IPN036721 | In distribution | |
| IPN927347 | In distribution | |
| IPN930715 | In distribution | |
| IPN037061 | In distribution | |
| IPN036968 | In distribution | |
| IPN030873 | Length 13 cm | In distribution |
| IPN930617 | In distribution | |
| IPN930615 | In distribution | |
| IPN919354 | In distribution | |
| IPN030213 | In distribution | |
| IPN035510 | Catheter Gauge 14 Fr | In distribution |
| IPN030210 | In distribution | |
| IPN927343 | In distribution | |
| IPN030099 | In distribution | |
| IPN030097 | Length 20 cm | In distribution |
| IPN030105 | In distribution | |
| IPN927362 | In distribution | |
| IPN036724 | In distribution | |
| IPN033961 | Catheter Gauge 12 Fr | In distribution |
| IPN036972 | In distribution | |
| IPN036969 | In distribution | |
| IPN035496 | Catheter Gauge 12 Fr | In distribution |
| IPN030074 | Catheter Gauge 14 Fr | In distribution |
| IPN030100 | Length 20 cm | In distribution |
| IPN032974 | Length 20 cm | In distribution |
| IPN035497 | Catheter Gauge 12 Fr | In distribution |
| IPN033988 | In distribution | |
| IPN036407 | In distribution | |
| IPN030217 | Length 20 cm | In distribution |
| IPN919964 | In distribution | |
| IPN030116 | Length 15 cm | In distribution |
| IPN033960 | Catheter Gauge 12 Fr | In distribution |
| IPN030171 | In distribution | |
| IPN035508 | Length 25 cm | In distribution |
| IPN036968 | In distribution | |
| IPN035501 | Catheter Gauge 12 Fr | In distribution |
| IPN036426 | In distribution | |
| IPN033993 | Catheter Gauge 14 Fr | In distribution |
| IPN919779 | In distribution | |
| IPN035490 | Length 13 cm | In distribution |
| IPN036960 | In distribution | |
| IPN033910 | Catheter Gauge 14 Fr | In distribution |
| IPN030116 | Catheter Gauge 14 Fr | In distribution |
| IPN035507 | Catheter Gauge 12 Fr | In distribution |
| IPN930714 | In distribution | |
| IPN036970 | In distribution | |
| IPN030106 | Catheter Gauge 12 Fr | In distribution |
| IPN029724 | In distribution | |
| IPN038325 | In distribution | |
| IPN030206 | Length 13 cm | In distribution |
| IPN032967 | Length 16 cm | In distribution |
| IPN036958 | In distribution | |
| IPN927363 | In distribution | |
| IPN035485 | Catheter Gauge 14 Fr | In distribution |
| IPN033988 | In distribution | |
| IPN035502 | Length 20 cm | In distribution |
| IPN033989 | Catheter Gauge 12 Fr | In distribution |
| IPN919693 | In distribution | |
| IPN030149 | Catheter Gauge 12 Fr | In distribution |
| IPN035498 | Length 20 cm | In distribution |
| IPN036967 | In distribution | |
| IPN032924 | Catheter Gauge 12 Fr | In distribution |
| IPN035483 | Length 16 cm | In distribution |
| IPN927355 | In distribution | |
| IPN030206 | Catheter Gauge 12 Fr | In distribution |
| IPN036426 | In distribution | |
| IPN033201 | Catheter Gauge 12 Fr | In distribution |
| IPN030070 | Catheter Gauge 14 Fr | In distribution |
| IPN030215 | Length 20 cm | In distribution |
| IPN030881 | Length 20 cm | In distribution |
| IPN029625 | In distribution | |
| IPN033204 | Length 20 cm | In distribution |
| IPN037573 | In distribution | |
| IPN030215 | Length 20 cm | In distribution |
| IPN036972 | In distribution | |
| IPN930575 | In distribution | |
| IPN033962 | In distribution | |
| IPN035508 | Length 25 cm | In distribution |
| IPN038321 | In distribution | |
| IPN036428 | In distribution | |
| IPN030212 | Length 13 cm | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Mahurkar Elite | Mozarc Medical US LLC | 119 |
| DUO-Flow® | Medical Components Inc | 106 |
| 400XL | Medical Components Inc | 95 |
| DUO-Split® | Medical Components Inc | 69 |
| Soft-Line® Duo-Flow® | Medical Components Inc | 58 |
| Mahurkar | Mozarc Medical US LLC | 48 |
| Disposable Hemodialysis Access Catheter Set | Guangdong Baihe Medical Technology Co., Ltd. | 38 |
| Disposable Hemodialysis Access Catheter Set Double Lumen14F*16cm(Straight) | Guangdong Baihe Medical Technology Co., Ltd. | 31 |
| Turbo-Flo HD | Cook Incorporated | 28 |
| Duoglide | Bard Access Systems, Inc. | 24 |
| Niagara catheter | Bard Access Systems, Inc. | 23 |
| Niagara Slim-Cath catheter | Bard Access Systems, Inc. | 21 |
Showing 12 of 59. All products under Catheter, Hemodialysis, Non-Implanted
Recalls Naming This Product
5 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 |
|---|---|---|---|---|---|---|---|
| Arrow International, LLC (subsidiary of Teleflex, Incorporated) | 510(k) number | 2026-04-21 | Class I | Nonconforming Material/Component | Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-bas | 15,425 | |
| Arrow International, LLC (subsidiary of Teleflex, Incorporated) | 510(k) number | 2017-12-22 | Class II | Process control | Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the product cannot be guaranteed. | 2020-05-27 | |
| Arrow International, LLC (subsidiary of Teleflex, Incorporated) | 510(k) number | 2017-10-17 | Class II | Process control | These finished good kits may contain the incorrect Springwire Guide (SWG). | 5,926 total | 2020-04-14 |
| Arrow International, LLC (subsidiary of Teleflex, Incorporated) | 510(k) number | 2017-05-09 | Class II | Packaging | Arrow International is recalling the affected product because the packaging may not be completely sealed, which may compromise sterility. | 27,485 units distributed in the U.S., 4,371 units distribute | 2018-09-17 |
| Arrow International, LLC (subsidiary of Teleflex, Incorporated) | 510(k) number | 2004-02-18 | Not classified | Other | catheter slips out of the suture wing during use. | 6610 UNITS | 2004-08-19 |
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.