FDA UDI
In Commercial Distribution
🇺🇸 United States
enableCV Introducer Sheath
DI: 00840479401256
·
Model: IS19A
·
ENABLECV INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- enableCV Introducer Sheath
- Primary DI
- 00840479401256
- Version / Model
- IS19A
- Company Name
- ENABLECV INC.
- Labeler DUNS
- 119247843
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-02-26
- Public Version
- 1
- Public Version Date
- 2026-03-06
- Public Version Status
- New
- Public Device Record Key
- 41f8f6bc-83ef-4a61-bbe1-a707b95c5c96
Device Description
Introducer Sheath - IS19A
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- 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
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| DYB | Introducer, Catheter | Cardiovascular | 870.1340 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58865 | Vascular catheter introduction set, nonimplantable | A collection of nonimplantable, invasive devices intended to provide percutaneous vascular access to enable introduction of a catheter (not included) into the vascular system. It includes a non-steerable introducer sheath with an inner obturator/dilator, and typically an additional access device(s) [e.g., guidewire, introducer needle, syringe, additional dilators] which may include a haemostatic valve to control blood loss, usually to enable arterial access. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00840479401263 | GS1 | 1 | In Commercial Distribution | ||
| Primary | 00840479401256 | GS1 |
Customer Contacts
- Phone
- 1(888)943-2783
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K972570 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 19 Fr (6.3 mm) x 3.7" (9.4 cm) |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store sterile packaged device in a cool dry place.