Lumiflex
- Primary DI
- 00724995244651
- Brand
- Lumiflex
- Company
- US Endoscopy
- Model
- 00715518
- Catalog number
- 00715518
- Device description
- LUMIFLEX 3-STAGE Balloon Dilatation Catheter 5.5cm/18mm no wire is made of nylon and is a progressive stage balloon capable of three disctinct and progressively larger diameters via controlled radial expansion.
- Published
- 2025-06-03
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- Sterile
- true
- Single use
- true
Contact Domains#
xx.xxProduct Codes#
Product Code Classifications#
Premarket Submissions#
| Submission | Supplement |
|---|---|
| K241888 | 000 |
Premarket Details#
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 00724995244651 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|---|---|---|
| 00724995244651 | 00724995244651 | 724995244651 | 0724995244651 |
GMDN Terms#
| Term | Definition |
|---|---|
| Gastrointestinal/biliary dilation balloon catheter, non-medicated | A long, thin, flexible tube with an inflatable balloon at its distal tip intended to be used for gastrointestinal and/or biliary intraluminal dilation; it is typically used to endoscopically dilate strictures of the oesophagus, pylorus, colon and/or biliary tract. The balloon is inflated to its prescribed diameter to widen the affected passage of the tract. The device may consist of one or more lumen, may be of the fixed-wire or wire-guided type, and is not coated with a drug/pharmaceutical. This is a single-use device. |
Device Sizes#
| Type | Value | Unit |
|---|---|---|
| Balloon Length | 5.5 | Centimeter |
| Catheter Length | 240 | Centimeter |
Storage And Handling#
| Type | Low | High | Condition |
|---|---|---|---|
| Special Storage Condition, Specify | 0 | 0 | Store in a dark, dry and ventilated place to prevent impact by rain, snow and ground moisture. Do not store near pollution or toxic chemicals materials. |
Sterilization Methods#
| Method |
|---|
Contacts#
| Phone | |
|---|---|
| +1(800)548-4873 | xx@xx.xx |
Regulatory Flags#
- DUNS number
- 627879687
- Device count
- 1
- Lot or batch
- true
- Manufacturing date on label
- true
- Expiration date on label
- true
Other Devices From This Company#
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 00724995182557 | Exacto | 00711094 | 00711094 | 2021-03-31 |
| 00724995182564 | Exacto | 00711095 | 00711095 | 2021-03-31 |
| 00724995182618 | Exacto | 00711115 | 00711115 | 2021-03-31 |
| 00724995243746 | Exacto Mundo | 00711114 | 00711114 | 2025-01-31 |
| 00724995180959 | VIA | 00717001 | 00717001 | 2020-01-31 |
| 00724995181116 | VIA | 00717019 | 00717019 | 2020-01-30 |
| 00724995181420 | VIA | 00717051 | 00717051 | 2020-01-30 |
| 00724995181451 | VIA | 00717054 | 00717054 | 2020-01-30 |
| 00724995181505 | VIA | 00717059 | 00717059 | 2020-01-30 |
| 00724995181659 | VIA | 00717076 | 00717076 | 2020-01-30 |
| 00724995182984 | VIA | 00717141 | 00717141 | 2020-01-30 |
| 00724995183073 | VIA | 00717155 | 00717155 | 2020-07-16 |
| 00724995183141 | VIA | 00717167 | 00717167 | 2020-01-30 |
| 00724995183257 | VIA | 00717182 | 00717182 | 2020-01-30 |
| 00724995190699 | VIA | 00717223 | 00717223 | 2020-01-30 |
| 00724995190736 | VIA | 00717234 | 00717234 | 2020-01-30 |
| 00724995193966 | VIA | 00717269 | 00717269 | 2020-02-04 |
| 00724995194123 | VIA | 00717229 | 00717229 | 2020-02-07 |
| 00724995194987 | VIA | 00717310 | 00717310 | 2020-03-23 |
| 00724995203412 | VIA | 00717337 | 00717337 | 2020-10-20 |
Other Devices Sharing Product Codes#
| Primary DI | Brand | Company | Product code | Published |
|---|---|---|---|---|
| 15711055100400 | M-Drain | Mermaid Medical A/S | FGE | 2024-10-01 |
| 15711055110041 | M-Drain | Mermaid Medical A/S | FGE | 2024-07-20 |
| 15711055110409 | M-Drain | Mermaid Medical A/S | FGE | 2024-07-20 |
| 15711055120040 | M-Drain | Mermaid Medical A/S | FGE | 2024-01-31 |
| 15711055120453 | M-Drain | Mermaid Medical A/S | FGE | 2024-01-31 |
| 08714729163039 | XXL™ Esophageal | BOSTON SCIENTIFIC CORPORATION | KNQ | 2016-09-24 |
| 08714729163053 | XXL™ Esophageal | BOSTON SCIENTIFIC CORPORATION | KNQ | 2016-09-24 |
| 08714729163060 | XXL™ Esophageal | BOSTON SCIENTIFIC CORPORATION | KNQ | 2016-09-24 |
| 08714729163084 | XXL™ Esophageal | BOSTON SCIENTIFIC CORPORATION | KNQ | 2016-09-24 |
| 08714729163114 | XXL™ Esophageal | BOSTON SCIENTIFIC CORPORATION | KNQ | 2016-09-24 |
| 08714729163121 | XXL™ Esophageal | BOSTON SCIENTIFIC CORPORATION | KNQ | 2016-09-24 |
| 08714729163145 | XXL™ Esophageal | BOSTON SCIENTIFIC CORPORATION | KNQ | 2016-09-24 |
| 08714729163169 | XXL™ Esophageal | BOSTON SCIENTIFIC CORPORATION | KNQ | 2016-09-24 |
| 08714729163176 | XXL™ Esophageal | BOSTON SCIENTIFIC CORPORATION | KNQ | 2016-09-24 |
| 08714729163190 | XXL™ Esophageal | BOSTON SCIENTIFIC CORPORATION | KNQ | 2016-09-24 |
| 08714729195986 | CRE Fixed Wire | BOSTON SCIENTIFIC CORPORATION | KNQ | 2016-09-24 |
| 08714729195993 | CRE Fixed Wire | BOSTON SCIENTIFIC CORPORATION | KNQ | 2016-09-24 |
| 08714729202011 | CRE Fixed Wire | BOSTON SCIENTIFIC CORPORATION | KNQ | 2016-09-24 |
| 15711055000311 | M-Drain | Mermaid Medical A/S | FGE | 2016-09-24 |
| 15711055000328 | M-Drain | Mermaid Medical A/S | FGE | 2016-09-24 |
| 15711055000359 | M-Drain | Mermaid Medical A/S | FGE | 2016-09-24 |
| 15711055000373 | M-Drain | Mermaid Medical A/S | FGE | 2016-09-24 |
| 15711055000410 | M-Drain | Mermaid Medical A/S | FGE | 2016-09-24 |
| 15711055000434 | M-Drain | Mermaid Medical A/S | FGE | 2016-09-24 |
| 15711055000458 | M-Drain | Mermaid Medical A/S | FGE | 2016-09-24 |
| 15711055000472 | M-Drain | Mermaid Medical A/S | FGE | 2016-09-24 |
| 15711055000496 | M-Drain | Mermaid Medical A/S | FGE | 2016-09-24 |
| 15711055000519 | M-Drain | Mermaid Medical A/S | FGE | 2016-09-24 |
| 15711055000533 | M-Drain | Mermaid Medical A/S | FGE | 2016-09-24 |
| 15711055000557 | M-Drain | Mermaid Medical A/S | FGE | 2016-09-24 |