FDA UDI
In Commercial Distribution
🇺🇸 United States
Arrow Pump Adapter - 5 Pack - for use with the Mega 8 Fr. 50cc IAB only
DI: 10607567107479
·
Model: 0684-00-0510-02
·
DATASCOPE CORP.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Arrow Pump Adapter - 5 Pack - for use with the Mega 8 Fr. 50cc IAB only
- Primary DI
- 10607567107479
- Version / Model
- 0684-00-0510-02
- Catalog Number
- 0684-00-0510-02
- Company Name
- DATASCOPE CORP.
- Labeler DUNS
- 001660786
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-23
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 261d5252-1bb7-4e0d-9aae-bd0daef454e1
Device Description
Arrow Pump Adapter - 5 Pack - for use with the Mega 8 Fr. 50cc IAB only
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Ethylene Oxide
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| DSP | System, Balloon, Intra-Aortic And Control | Cardiovascular | 870.3535 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44036 | Intravascular catheter adaptor | A connecting device, usually a small part, intended to be used to join an applied catheter to an external device(s) used in the intravenous administration of fluids to a patient. This device will typically be used when the devices to be connected are from different manufacturers and are non-compatible, enabling them to mate together. This is a single-use device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10607567107479 | GS1 |
Customer Contacts
- Phone
- 888-627-8383
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K133074 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Catheter Gauge | 8 | French |