| Primary Device ID | 00842289102453 |
| NIH Device Record Key | 4ca3ecc9-0d2a-459e-b5c3-86a02a056a38 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | masterguard plus HEMODIALYSIS FISTULA NEEDLE SET |
| Version Model Number | D9-7016MGP |
| Company DUNS | 088013219 |
| Company Name | NXSTAGE MEDICAL, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | 1-866-697-8243 |
| info@nxstage.com | |
| Phone | 1-866-697-8243 |
| info@nxstage.com | |
| Phone | 1-866-697-8243 |
| info@nxstage.com | |
| Phone | 1-866-697-8243 |
| info@nxstage.com | |
| Phone | 1-866-697-8243 |
| info@nxstage.com | |
| Phone | 1-866-697-8243 |
| info@nxstage.com | |
| Phone | 1-866-697-8243 |
| info@nxstage.com | |
| Phone | 1-866-697-8243 |
| info@nxstage.com | |
| Phone | 1-866-697-8243 |
| info@nxstage.com | |
| Phone | 1-866-697-8243 |
| info@nxstage.com | |
| Phone | 1-866-697-8243 |
| info@nxstage.com | |
| Phone | 1-866-697-8243 |
| info@nxstage.com | |
| Phone | 1-866-697-8243 |
| info@nxstage.com |
| Needle Gauge | 16 Gauge |
| Length | 1.25 Inch |
| Needle Gauge | 16 Gauge |
| Length | 1.25 Inch |
| Needle Gauge | 16 Gauge |
| Length | 1.25 Inch |
| Needle Gauge | 16 Gauge |
| Length | 1.25 Inch |
| Needle Gauge | 16 Gauge |
| Length | 1.25 Inch |
| Needle Gauge | 16 Gauge |
| Length | 1.25 Inch |
| Needle Gauge | 16 Gauge |
| Length | 1.25 Inch |
| Needle Gauge | 16 Gauge |
| Length | 1.25 Inch |
| Needle Gauge | 16 Gauge |
| Length | 1.25 Inch |
| Needle Gauge | 16 Gauge |
| Length | 1.25 Inch |
| Needle Gauge | 16 Gauge |
| Length | 1.25 Inch |
| Needle Gauge | 16 Gauge |
| Length | 1.25 Inch |
| Needle Gauge | 16 Gauge |
| Length | 1.25 Inch |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00842289102453 [Primary] |
| FIE | Needle, Fistula |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-07-16 |
| Device Publish Date | 2020-07-08 |
| 00842289102385 | SINGLE PACK FISTULA NEEDLE 15G X 1" WITH MASTERGUARD PLUS INCLUDED WITH TWINPACK D9-2005MGP |
| 00842289102453 | SINGLE PACK FISTULA NEEDLE 16G X 1 1/4" WITH MASTERGUARD PLUS INCLUDED WITH TWINPACK D9-2016MGP |
| 00842289102446 | SINGLE PACK FISTULA NEEDLE 15G X 1 1/4" WITH MASTERGUARD PLUS INCLUDED WITH TWINPACK D9-2015MGP |
| 00842289102439 | SINGLE PACK FISTULA NEEDLE 17G X 1" LONG BEVEL WITH MASTERGUARD PLUS INCLUDED WITH TWINPACK D9-2 |
| 00842289102422 | SINGLE PACK FISTULA NEEDLE 17G X 1" WITH MASTERGUARD PLUS INCLUDED WITH TWINPACK D9-2007MGP |
| 00842289102415 | SINGLE PACK FISTULA NEEDLE 16G X 1" LONG BEVEL WITH MASTERGUARD PLUS INCLUDED WITH TWINPACK D9-2 |
| 00842289102408 | SINGLE PACK FISTULA NEEDLE SET 16G X 1" WITH MASTERGUARD PLUS INCLUDED WITH TWINPACK D9-2006MGP |
| 00842289102392 | SINGLE PACK FISTULA NEEDLE 15G X 1" LONG BEVEL WITH MASTERGUARD PLUS INCLUDED WITH TWINPACK D9-2 |
| 00842289102378 | SINGLE PACK FISTULA NEEDLE 14G X 1" WITH MASTERGUARD PLUS INCLUDED WITH TWINPACK D9-2004MGP |
| 10842289102863 | S9-7007MGPLB |
| 10842289102856 | S9-7007MGP |
| 00842289102361 | SINGLE PACK FISTULA NEEDLE 15G X 1" ROTATABLE HUB WITH MASTERGUARD PLUS INCLUDED WITH TWINPACK D |