ButtonHole With SteriPick Twinpack+ Needle SET
Twinpack Buttonhole Fistula Needle SET 17G X 3/5" W/ Steripick Total Case QTY 250 (115 Twin Pouches + 20 Single Pouches)
4manufacturers in China registered for this device type
14catalogue numbers in this listing
1510(k) clearance
2recalls on this code
Who Else Makes It
All of them in Guangdong.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Guangzhou Huada Biotechnology Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 9 |
| Guangzhou Kaiheng K&S Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 9 |
| Bain Medical Equipment(Guangzhou) Co., Ltd. | Guangzhou | Guangdong | Manufacturer | 3 |
| Vital Healthcare (Guangzhou) Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 3 |
Record
| Listed by | Nxstage Medical, Inc., United States |
|---|---|
| FDA product code | FIE |
| Device type | Needle, Fistula |
| Device class | Class 2 |
| Regulation | 21 CFR 876.5540 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| Record published | 2020-06-24 |
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, expiry date |
| Storage | Storage environment temperature 0 to 40 °C; Special storage condition: Keep dry |
| Sizes | Needle gauge 14 to 17 G; length 0.6 to 1 in |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| BH-2036PE | Needle Gauge 16 G | In distribution |
| BH-2004PE | Needle Gauge 14 G | In distribution |
| BH-2037PE | Needle Gauge 17 G | In distribution |
| BH-2037PE | Needle Gauge 17 G | In distribution |
| BH-2005PE | Needle Gauge 15 G | In distribution |
| BH-2007PE | Needle Gauge 17 G | In distribution |
| BH-2035PE | Needle Gauge 15 G | In distribution |
| BH-2007PE | Needle Gauge 17 G | In distribution |
| BH-2036PE | Needle Gauge 16 G | In distribution |
| BH-2035PE | Needle Gauge 15 G | In distribution |
| BH-2006PE | Needle Gauge 16 G | In distribution |
| BH-2006PE | Needle Gauge 16 G | In distribution |
| BH-2004PE | Needle Gauge 14 G | In distribution |
| BH-2005PE | Needle Gauge 15 G | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Medisystems Hemodialysis Fistula Needle Set with MasterGuard | Medisystems Corp. | 72 |
| Medisystems TwinPack Hemodialysis Fistula Needle Set with MasterGuard | Medisystems Corp. | 44 |
| masterguard plus Hemodialysis Fistula Needle SET | Nxstage Medical, Inc. | 35 |
| masterguard plus Twinpack+ Hemodialysis Fistula Needle Sets | Nxstage Medical, Inc. | 20 |
| Dora | Bain Medical Equipment(Guangzhou) Co., Ltd. | 17 |
| JMS Wingeater A.v.fistula Needle SET | JMS Singapore PTE. Ltd | 15 |
| Medisystems Button Hole Needle Set | Medisystems Corp. | 14 |
| Medisystems TwinPack ButtonHole Needle Set with SteriPick | Medisystems Corp. | 14 |
| ButtonHole with SteriPick Needle SET | Nxstage Medical, Inc. | 14 |
| Medisystems Button Hole Needle Set with SteriPick | Medisystems Corp. | 14 |
| JMS A.V. Fistula Needle SET | JMS Singapore PTE. Ltd | 11 |
| JMS Harmony A.v.fistula Needle SET | JMS Singapore PTE. Ltd | 10 |
Showing 12 of 32. All products under Needle, Fistula
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K134019 | 2014-09-11 |
Recalls
2 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 |
|---|---|---|---|---|---|
| 2012-12-20 | Class II | Labeling mix-ups | Single needle packs in each case ( 10 needles per case) are mislabeled on the pouch as 15 Gauge needles instead of 17 Gauge | 16 cases (15 cs x 250 ea) 4,000 needles | 2013-10-10 |
| 2012-12-20 | Class II | Labeling mix-ups | A total of 5 (ea) single needle pouches are mislabeled as 15 Ga x1″ instead of 15 Ga x 3/5″. | 26 casesx 250 needles (6500needles) | 2013-10-10 |
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.