Masterguard Plus Hemodialysis Fistula Needle SET
Single Pack Fistula Needle 15G X 1" Rotatable HUB With Masterguard Plus Included With Twinpack D9-6005MGP
4manufacturers in China registered for this device type
35catalogue 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 | 2020-07-16 |
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 | Shipping box of 250, shipping box of 200 |
| Sizes | Needle gauge 14 to 18 G; length 0.6 to 1.25 in |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| D9-4005MGP | Needle Gauge 15 G | In distribution |
| S9-7436MGP | Needle Gauge 16 G | In distribution |
| S9-7005MGPLB | Needle Gauge 15 G | In distribution |
| S9-7007MGP | Needle Gauge 17 G | In distribution |
| S9-7606MGP | Needle Gauge 16 G | In distribution |
| S9-7005MGP | Needle Gauge 15 G | In distribution |
| S9-7616MGP | Needle Gauge 16 G | In distribution |
| S9-4015MGP | Needle Gauge 15 G | In distribution |
| S9-7006MGPLB | Needle Gauge 16 G | In distribution |
| S9-7437MGP | Needle Gauge 17 G | In distribution |
| D9-7006MGPLB | Needle Gauge 16 G | In distribution |
| S9-4006MGP | Needle Gauge 16 G | In distribution |
| S9-7016MGP | Needle Gauge 16 G | In distribution |
| S9-7008MGP | Needle Gauge 18 G | In distribution |
| S9-7605MGP | Needle Gauge 15 G | In distribution |
| S9-7017MGP | Needle Gauge 17 G | In distribution |
| S9-7006MGP | Needle Gauge 16 G | In distribution |
| D9-7015MGP | Needle Gauge 15 G | In distribution |
| D9-7005MGPLB | Needle Gauge 15 G | In distribution |
| S9-4005MGP | Needle Gauge 15 G | In distribution |
| D9-7005MGP | Needle Gauge 15 G | In distribution |
| D9-7016MGP | Needle Gauge 16 G | In distribution |
| S9-7004MGP | Needle Gauge 14 G | In distribution |
| S9-4007MGP | Needle Gauge 17 G | In distribution |
| S9-4017MGP | Needle Gauge 17 G | In distribution |
| S9-7015MGP | Needle Gauge 15 G | In distribution |
| D9-7007MGPLB | Needle Gauge 17 G | In distribution |
| S9-7615MGP | Needle Gauge 15 G | In distribution |
| S9-7014MGP | Needle Gauge 14 G | In distribution |
| S9-7007MGPLB | Needle Gauge 17 G | In distribution |
| D9-7004MGP | Needle Gauge 14 G | In distribution |
| S9-4016MGP | Needle Gauge 16 G | In distribution |
| D9-7006MGP | Needle Gauge 16 G | In distribution |
| D9-7007MGP | Needle Gauge 17 G | In distribution |
| S9-7435MGP | 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 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 |
| 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.