Zyno
- Primary DI
- 10814371020065
- Brand
- Zyno
- Company
- ZYNO MEDICAL LLC
- Model
- A2-80071-D
- Catalog number
- A2-80071-D
- Device description
- "A2 Administration Primary Set: 105"" 1 NF Y-Site Below Pump, Roller Clamp. A2 Primary Administration Sets are single-use IV administration sets for use with Z-800 Zyno Medical Infusion pump. All A2 Primary sets fluid paths are sterile, non-Pyrogenic, are not made with natural rubber latex, and are not made with DEHP."
- Published
- 2016-09-23
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- Sterile
- true
- Single use
- true
Product Codes#
| Code | Name |
|---|---|
| FPA | Set, Administration, Intravascular |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| FPA | Set, Administration, Intravascular | General Hospital | 2 |
Premarket Submissions#
| Submission | Supplement |
|---|---|
| K132841 | 000 |
Premarket Details#
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 10814371020065 | Primary | GS1 | 0 | |
| 00814371020068 | Unit of Use | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|---|---|---|
| 10814371020065 | 10814371020065 | ||
| 00814371020068 | 00814371020068 | 814371020068 | 0814371020068 |
GMDN Terms#
| Term | Definition |
|---|---|
| Electric infusion pump administration set, single-use | A collection of sterile devices (e.g., plastic tubing, check valve, roller clamp, Y-site connector, Luer, needle/catheter) intended to be used in combination with an electrically-powered infusion pump for the intravenous (IV), subcutaneous, intramuscular, or epidural administration of medication. This is a single-use device. |
Regulatory Flags#
- DUNS number
- 030899271
- Device count
- 50
- Lot or batch
- true
- Expiration date on label
- true
- No natural rubber latex
- true
Other Devices From This Company#
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 00814371020013 | Z-800F | Z-800F | Z-800F | 2015-10-13 |
| 00814371020020 | Z-800W | Z-800W | Z-800W | 2015-10-13 |
| 00814371020037 | Z-800WF | Z-800WF | Z-800WF | 2015-10-13 |
| 00814371020044 | Nimbus | Nimbus | Nimbus | 2015-10-13 |
| 00814371020006 | Z-800 | Z-800 | Z-800 | 2015-10-13 |
| 10814371020058 | Zyno | A2-80070 | A2-80070 | 2016-09-23 |
| 10814371020072 | Zyno | A2-80071-DF | A2-80071-DF | 2016-09-23 |
| 10814371020089 | Zyno | A2-80071-DF120 | A2-80071-DF120 | 2016-09-23 |
| 10814371020096 | Zyno | A2-80071-P | A2-80071-P | 2016-09-23 |
| 10814371020102 | Zyno | A2-80071-PF | A2-80071-PF | 2016-09-23 |
| 10814371020119 | Zyno | A2-80072 | A2-80072 | 2016-09-23 |
| 10814371020126 | Zyno | A2-80072-F | A2-80072-F | 2016-09-23 |
| 10814371020133 | Zyno | A2-80075 | A2-80075 | 2016-09-23 |
| 10814371020140 | Zyno | B2-70070 | B2-70070 | 2016-09-23 |
| 10814371020157 | Zyno | B2-70071-D | B2-70071-D | 2016-09-23 |
| 10814371020164 | Zyno | B2-70071-DF | B2-70071-DF | 2016-09-23 |
| 10814371020171 | Zyno | B2-70071-DF120 | B2-70071-DF120 | 2016-09-23 |
| 10814371020188 | Zyno | B2-70071-P | B2-70071-P | 2016-09-23 |
| 10814371020195 | Zyno | B2-70072 | B2-70072 | 2016-09-23 |
| 10814371020201 | Zyno | B2-70072-F | B2-70072-F | 2016-09-23 |
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