Medisystems Hemodialysis Fistula Needle Set With MasterGuard
Medisystems Twinpack Fistula Needle SET 15G X 1" Rotatable HUB With Masterguard Plus Included With Twinpack D9-6005MGP
4manufacturers in China registered for this device type
72catalogue numbers in this listing
6510(k) clearances naming this product code
1recall
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 | Medisystems Corp., United States |
|---|---|
| FDA product code | FIE |
| Device type | Needle, Fistula |
| Device class | Class 2 |
| Regulation | 21 CFR 876.5540 |
| Record published | 2016-09-16 |
| Record revised | 2021-02-23 (version 3) |
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 | Special storage condition: Keep dry; Storage environment temperature 0 to 40 °C |
| Packaging | Pack of 250, shipping box of 250, pack of 200, shipping box of 200 |
| Sizes | Length 0.6 to 1.25 in; needle gauge 14 to 18 G |
| Distribution end date | 2020-12-31 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| S9-7008MG | Length 1 in | In distribution |
| S9-7014MG | Length 1.25 in | In distribution |
| D9-7006MGP | Length 1 in | In distribution |
| D9-7005MGP | Length 1 in | In distribution |
| D9-4005MG | Length 1 in | Withdrawn |
| D9-7007MGP | Length 1 in | Withdrawn |
| S9-7004MG | Length 1 in | Withdrawn |
| S9-7437MG | Length 0.6 in | Withdrawn |
| S9-7007MGLB | Length 1 in | Withdrawn |
| S9-7007MGPLB | Length 1 in | Withdrawn |
| S9-7007MGP | Length 1 in | Withdrawn |
| S9-7015MGP | Length 1.25 in | Withdrawn |
| D9-7015MGP | Length 1.25 in | Withdrawn |
| S9-7435MG | Length 0.6 in | Withdrawn |
| S9-7006MGP | Length 1 in | Withdrawn |
| S9-4006MGP | Length 1 in | Withdrawn |
| S9-4016MG | Length 1.25 in | Withdrawn |
| S9-7015MG | Needle Gauge 15 G | Withdrawn |
| S9-7017MGP | Length 1.25 in | Withdrawn |
| S9-7615MG | Length 1.25 in | Withdrawn |
| S9-7005MG | Length 1 in | Withdrawn |
| S9-4015MGP | Length 1.25 in | Withdrawn |
| D9-7005MGPLB | Length 1 in | Withdrawn |
| S9-4017MGP | Length 1.25 in | Withdrawn |
| S9-7616MGP | Length 1.25 in | Withdrawn |
| D9-7015MG | Length 1.25 in | Withdrawn |
| S9-7005MGPLB | Length 1 in | Withdrawn |
| S9-7436MG | Length 0.6 in | Withdrawn |
| S9-7016MGP | Length 1.25 in | Withdrawn |
| S9-7606MG | Length 1 in | Withdrawn |
| S9-7006MG | Length 1 in | Withdrawn |
| D9-7007MGPLB | Length 1 in | Withdrawn |
| S9-7436MGP | Length 0.6 in | Withdrawn |
| S9-4005MGP | Length 1 in | Withdrawn |
| S9-4015MG | Length 1.25 in | Withdrawn |
| D9-7006MGPLB | Length 1 in | Withdrawn |
| S9-4006MG | Needle Gauge 16 G | Withdrawn |
| S9-7016MG | Length 1.25 in | Withdrawn |
| D9-7007MGLB | Length 1 in | Withdrawn |
| S9-7437MGP | Length 0.6 in | Withdrawn |
| D9-7007MG | Length 1 in | Withdrawn |
| S9-7004MGP | Length 1 in | Withdrawn |
| D9-7004MGP | Length 1 in | Withdrawn |
| D9-7006MGP | Length 1 in | Withdrawn |
| S9-4005MG | Length 1 in | Withdrawn |
| S9-7005MGLB | Length 1 in | Withdrawn |
| S9-7605MG | Length 1 in | Withdrawn |
| D9-7016MGP | Length 1.25 in | Withdrawn |
| S9-7435MGP | Length 0.6 in | Withdrawn |
| D9-4005MGP | Length 1 in | Withdrawn |
| S9-7606MGP | Length 1 in | Withdrawn |
| D9-7005MGLB | Length 1 in | Withdrawn |
| S9-7008MGP | Length 1 in | Withdrawn |
| S9-7006MGLB | Length 1 in | Withdrawn |
| S9-7616MG | Needle Gauge 16 G | Withdrawn |
| D9-7005MGP | Length 1 in | Withdrawn |
| S9-7605MGP | Length 1 in | Withdrawn |
| S9-4007MGP | Length 1 in | Withdrawn |
| S9-4017MG | Length 1.25 in | Withdrawn |
| S9-7007MG | Length 1 in | Withdrawn |
| D9-7004MG | Length 1 in | Withdrawn |
| S9-4007MG | Length 1 in | Withdrawn |
| D9-7005MG | Length 1 in | Withdrawn |
| S9-7006MGPLB | Length 1 in | Withdrawn |
| S9-4016MGP | Length 1.25 in | Withdrawn |
| D9-7006MG | Length 1 in | Withdrawn |
| D9-7006MGLB | Length 1 in | Withdrawn |
| S9-7017MG | Length 1.25 in | Withdrawn |
| S9-7014MGP | Length 1.25 in | Withdrawn |
| S9-7615MGP | Length 1.25 in | Withdrawn |
| D9-7016MG | Length 1.25 in | Withdrawn |
| S9-7005MGP | Length 1 in | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| 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 |
| 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 |
|---|---|
| K062953 | 2007-02-12 |
| K990803 | 2000-01-06 |
| K932074 | 1994-02-18 |
| K910734 | 1991-06-20 |
| K862002 | 1986-06-27 |
| K811838 | 1981-09-08 |
Recalls
The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2012-01-31 | Not classified | Employee error | Mislabeled outer carton: Outside shipping cartons is stamped 15Ga x 1″, product contained within properly labeled as 17Ga x 1″ needle | 20,750 units (83 cases) | 2012-09-12 |
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.