ButtonHole Single Needle SET
2 catalogue numbers from BH-3006, listed by Nxstage Medical, Inc., United States, under Needle, Fistula. 4 manufacturers in China are registered for this product code.
4manufacturers in China registered for this device type
2catalogue 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 | 2020-07-06 |
| Record revised | 2024-03-29 (version 2) |
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 |
| Packaging | Inner box of 30, shipping box of 10 |
| Sizes | Needle gauge 15 to 16 G; length 1 in |
| Distribution end date | 2024-03-28 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| BH-3006 | Needle Gauge 16 G | Withdrawn |
| BH-3005 | Needle Gauge 15 G | Withdrawn |
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 |
| ButtonHole with SteriPick Twinpack+ Needle SET | Nxstage Medical, Inc. | 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 |
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.