Thalaset™
Sub Q infusion set. Single use infusion set for subcutaneous infusion. The infusion set must be used as described in the Instruction for Use.
49manufacturers in China registered for this device type
36catalogue numbers in this listing
12510(k) clearances naming this product code
13recalls on this code
Who Else Makes It
Concentrated in Zhejiang (12), Jiangsu (11), Shanghai (10). 13 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Promisemed Hangzhou Meditech Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 21 |
| Hantech Medical Device Co., Ltd. | Cixi | Zhejiang | Contract manufacturer | 18 |
| Forefront Medical Technology (Jiangsu) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 14 |
| BQ Plus Medical Co., Ltd. | Songjiang | Shanghai | Contract manufacturer | 13 |
| Ningbo Tianyi Medical Appliance Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 11 |
| Anhui Tiankang Medical Technology Co., Ltd. | Tianchang | Anhui | Contract manufacturer | 9 |
| Anhui Kangda Medical Products Co., Ltd. | Tianchang | Anhui | Contract manufacturer | 7 |
| JDI Electronics Factory | Dongguan | Guangdong | Contract manufacturer | 7 |
| Yangzhou Xingwei Medical Technology Co., Ltd. | Yangzhou | Jiangsu | Contract manufacturer | 5 |
| Wenzhou K.L.F. Medical Plastics Co., Ltd. | Wenzhou | Zhejiang | Contract manufacturer | 4 |
| Advance Technology Ltd | Shenzhen | Guangdong | Contract manufacturer | 3 |
| Weihai Jierui Medical Products Co., Ltd. | Weihai | Shandong | Contract manufacturer | 3 |
Showing 12 of 49. All 49 manufacturers in China registered for Set, Administration, Intravascular
Record
| Listed by | Unomedical A/S, Denmark |
|---|---|
| FDA product code | FPA |
| Device type | Set, Administration, Intravascular |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5440 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| Record published | 2016-09-15 |
| Record revised | 2024-05-10 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Special storage condition: Protect from direct sunlight. Store at room temperature |
| Packaging | Outer box of 200 |
| Sizes | Length 60 to 110 cm; depth 6 to 10 mm; angle 90 ° |
| Distribution end date | 2024-05-09 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 71-060-2738 | Length 60 cm | 10 | Withdrawn |
| 71-060-2736 | Length 60 cm | 10 | Withdrawn |
| 71-080-2938 | Length 80 cm | 10 | Withdrawn |
| 71-110-2931 | Length 110 cm | 10 | Withdrawn |
| 71-080-2938 | Length 80 cm | 10 | Withdrawn |
| 71-110-2936 | Length 110 cm | 10 | Withdrawn |
| 71-110-2736 | Length 110 cm | 10 | Withdrawn |
| 71-060-2938 | Length 60 cm | 10 | Withdrawn |
| 71-060-2731 | Length 60 cm | 10 | Withdrawn |
| 71-080-2938 | Length 80 cm | 10 | Withdrawn |
| 71-060-2731 | Length 60 cm | 10 | Withdrawn |
| 71-060-2931 | Length 60 cm | 10 | Withdrawn |
| 71-080-2738 | Length 80 cm | 10 | Withdrawn |
| 71-110-2931 | Length 110 cm | 10 | Withdrawn |
| 71-080-2936 | Length 80 cm | 10 | Withdrawn |
| 71-110-2936 | Length 110 cm | 10 | Withdrawn |
| 71-110-2938 | Length 110 cm | 10 | Withdrawn |
| 71-080-2736 | Length 80 cm | 10 | Withdrawn |
| 71-060-2936 | Length 60 cm | 10 | Withdrawn |
| 71-110-2938 | Length 110 cm | 10 | Withdrawn |
| 71-060-2738 | Length 60 cm | 10 | Withdrawn |
| 71-080-2738 | Length 80 cm | 10 | Withdrawn |
| 71-110-2736 | Length 110 cm | 10 | Withdrawn |
| 71-080-2731 | Length 80 cm | 10 | Withdrawn |
| 71-110-2731 | Length 110 cm | 10 | Withdrawn |
| 71-080-2731 | Length 80 cm | 10 | Withdrawn |
| 71-110-2738 | Length 110 cm | 10 | Withdrawn |
| 71-080-2936 | Length 80 cm | 10 | Withdrawn |
| 71-060-2738 | Length 60 cm | 10 | Withdrawn |
| 71-060-2938 | Length 60 cm | 10 | Withdrawn |
| 71-110-2738 | Length 110 cm | 10 | Withdrawn |
| 71-080-2936 | Length 80 cm | 10 | Withdrawn |
| 71-060-2738 | Length 60 cm | 10 | Withdrawn |
| 71-060-2738 | Length 60 cm | 10 | Withdrawn |
| 71-080-2931 | Length 80 cm | 10 | Withdrawn |
| 71-110-2731 | Length 110 cm | 10 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| ICU Medical | ICU Medical, Inc | 529 |
| Codan | Codan US Corp. | 510 |
| Vygon | Vygon Corp. | 355 |
| Port Access Needle | Bard Access Systems, Inc. | 341 |
| Set, Administration, Intravascular | Mps Medical, Inc. | 291 |
| Alaris, SmartSite | BD Switzerland Sàrl | 266 |
| IV Administration Set | B. Braun Medical Inc. | 242 |
| Medex | ICU Medical, Inc | 237 |
| Extension Set | B. Braun Medical Inc. | 171 |
| MaxGuard | BD Switzerland Sàrl | 150 |
| Medline | Medline Industries, Inc. | 148 |
| Centurion | Centurion Medical Products Corporation | 145 |
Showing 12 of 768. All products under Set, Administration, Intravascular
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K210544 | 2021-07-16 |
| K192647 | 2019-12-13 |
| K173879 | 2018-03-05 |
| K162812 | 2017-11-01 |
| K160648 | 2016-08-10 |
| K132142 | 2013-10-08 |
| K070430 | 2007-04-04 |
| K061374 | 2006-07-31 |
| K051264 | 2005-09-01 |
| K041545 | 2004-06-30 |
| K040633 | 2004-04-01 |
| K032854 | 2003-10-09 |
Recalls
3 of these are Class I. Class I is the FDA’s most serious grade: a reasonable probability of serious injury or death. 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 |
|---|---|---|---|---|---|
| 2024-07-23 | Class II | Process change control | Specific VariSoftTM Infusion Sets were packaged using incorrect secondary packaging (boxes) branded “Trusteel Infusion Set”. | ||
| 2024-03-05 | Class II | Device Design | Specific lots of Neria Soft Infusion Sets, which have been shipped into the US Market, have been shipped with the incorrect Instruction for Use (IFU) within the final pack. The IFU included is the IFU registered for the Rest of World (ROW) | 10,770 units | |
| 2023-10-11 | Class I | Process change control | The Varisoft infusion set is used in conjunction with tandem insulin pumps. The defect reported was damage to the connector piece during manufacturing. This damage results in the connector becoming detached more easily from the insulin set | 1679 units | |
| 2023-10-11 | Class I | Process change control | The Varisoft infusion set is used in conjunction with tandem insulin pumps. The defect reported was damage to the connector piece during manufacturing. This damage results in the connector becoming detached more easily from the insulin set | 8028 units | |
| 2023-10-11 | Class I | Process change control | The Varisoft infusion set is used in conjunction with tandem insulin pumps. The defect reported was damage to the connector piece during manufacturing. This damage results in the connector becoming detached more easily from the insulin set | 3362 units | |
| 2022-07-21 | Class II | Labeling Change Control | The IFU incorrectly states the insulin fill value of two sizes of cannula which can result in an initial insulin infusion to be fewer units than intended. | 1,643,320 units | 2026-05-04 |
| 2015-05-21 | Class II | Nonconforming Material/Component | Unomedical has found that in rare cases the steel needle can break during use, interrupting the delivery of medication including insulin. | 22,976,870 units | 2017-01-23 |
| 2014-11-07 | Class II | Device Design | Tubing detachment | 664,000 units | 2016-11-16 |
| 2014-11-07 | Class II | Device Design | Tubing detachment | 9,782,880 units | 2016-11-16 |
| 2014-11-07 | Class II | Device Design | Tubing detachment | 1,295,515 units | 2016-11-16 |
| 2014-11-07 | Class II | Device Design | Tubing detachment | 4,748,000 units | 2016-11-16 |
| 2014-11-07 | Class II | Device Design | Tubing detachment | 653,280 units | 2016-11-16 |
| 2014-11-07 | Class II | Device Design | Tubing detachment | 22,114 units | 2016-11-16 |
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.