CooperSurgical, Inc.
- Primary DI
- 30888937003247
- Brand
- CooperSurgical, Inc.
- Company
- Coopersurgical, Inc.
- Model
- 47-9005
- Device description
- Adult Esophageal Balloon Catheter Set; PTFE Coated Stylet; 5 French
- Published
- 2016-09-15
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- true
- Single use
- true
Product Codes#
| Code | Name |
|---|---|
| GBA | Catheter, Balloon Type |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| GBA | Catheter, Balloon Type | General, Plastic Surgery | 1 |
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 20888937003240 | Package | GS1 | 5 | In Commercial Distribution |
| 30888937003247 | Package | GS1 | 20 | In Commercial Distribution |
| 60888937003248 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized |
|---|---|
| 20888937003240 | 20888937003240 |
| 30888937003247 | 30888937003247 |
| 60888937003248 | 60888937003248 |
GMDN Terms#
| Term | Definition |
|---|---|
| Oesophageal balloon catheter | A long, flexible device with an inflatable balloon(s) at its distal end designed to access the length of the oesophagus of adult and adolescent patients to dilate strictures through balloon inflation. It is typically constructed as a catheter of various designs and is usually used endoscopically to enable visualization during the procedure. It is typically used to dilate strictures due to oesophageal surgery, primary gastric reflux, radiation therapy, and dilatation of the cardia in patients with achalasia (failure to relax the lower oesophageal sphincter). This is a single-use device. |
Sterilization Methods#
| Method |
|---|
Regulatory Flags#
- DUNS number
- 801895244
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- true
- HCT/P
- false
- Kit
- true
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- false
- Expiration date on label
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- true
- Sterilization required before use
- false
Other Devices From This Company#
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 00888937027327 | ER-Spec | C020300 | 2026-08-05 | |
| 00888937027334 | ER-Spec | C020310 | 2026-08-05 | |
| 00888937027341 | ER-Spec | C020320 | 2026-08-05 | |
| 00888937027358 | HER-Spec | C020600 | 2026-08-05 | |
| 00888937027365 | HER-Spec | C020610 | 2026-08-05 | |
| 00888937027372 | HER-Spec | C020620 | 2026-08-05 | |
| 00888937027389 | OfficeSPEC | C020001 | 2026-08-06 | |
| 00888937027396 | HER-Spec | C020500 | 2026-08-06 | |
| 00888937027402 | HER-Spec | C020510 | 2026-08-06 | |
| 00888937027419 | HER-Spec | C020520 | 2026-08-06 | |
| 00888937027426 | ER-SPEC | C020100-1 | 2026-08-06 | |
| 00888937027433 | ER-SPEC | C020110-1 | 2026-08-06 | |
| 00888937027440 | ER-Spec | C020120-1 | 2026-08-06 | |
| 00888937027457 | ER-Spec | C020130-1 | 2026-08-06 | |
| 00888937027464 | ER-Spec | C020140-1 | 2026-08-06 | |
| 00888937027594 | AnoSPEC | C060100 | 2026-08-05 | |
| 00888937027600 | AnoSPEC | C060110 | 2026-08-05 | |
| 00888937027617 | AnoSPEC | C060120 | 2026-08-05 | |
| 00888937032833 | LifeGlobal® Coda® | Incubator Unit | GCIU-010-M | 2026-08-03 |
| 00888937032840 | LifeGlobal® Coda® | Filter for Incubator Unit | GCIF-001-M | 2026-08-03 |
Other Devices Sharing Product Codes#
| Primary DI | Brand | Company | Product code | Published |
|---|---|---|---|---|
| 04026704916955 | RUSCH | TELEFLEX INCORPORATED | GBA | 2026-08-03 |
| 00860014541704 | Envision | SPINAL STABILIZATION TECHNOLOGIES LIMITED | GBA | 2026-04-30 |
| 00860014541711 | Envision | SPINAL STABILIZATION TECHNOLOGIES LIMITED | GBA | 2026-04-30 |
| 06979032640031 | GOBEN | HUZHOU JUNDA INDUSTRY CO., LTD. | GBA | 2025-08-26 |
| M7403150006 | Verify | SPINEOLOGY INC. | GBA | 2023-06-26 |
| 00887482173718 | Symmetry Surgical® | ASPEN SURGICAL PRODUCTS, INC. | GBA | 2022-09-21 |
| 00678467004963 | Mui Scientific | H & A Mui Enterprises Inc | GBA | 2019-10-17 |
| 00678467005007 | Mui Scientific | H & A Mui Enterprises Inc | GBA | 2019-10-17 |
| 00678467005847 | Mui Scientific | H & A Mui Enterprises Inc | GBA | 2019-10-17 |
| 00678467005915 | Mui Scientific | H & A Mui Enterprises Inc | GBA | 2019-10-17 |
| 00678467006134 | Mui Scientific | H & A Mui Enterprises Inc | GBA | 2019-10-17 |
| 00678467006547 | Mui Scientific | H & A Mui Enterprises Inc | GBA | 2019-10-17 |
| 00678467006677 | Mui Scientific | H & A Mui Enterprises Inc | GBA | 2019-10-17 |
| 00678467006707 | Mui Scientific | H & A Mui Enterprises Inc | GBA | 2019-10-17 |
| 00678467006868 | Mui Scientific | H & A Mui Enterprises Inc | GBA | 2019-10-17 |
| 00678467506184 | Mui Scientific | H & A Mui Enterprises Inc | GBA | 2019-10-17 |
| 00678467506252 | Mui Scientific | H & A Mui Enterprises Inc | GBA | 2019-10-17 |
| 00678467506276 | Mui Scientific | H & A Mui Enterprises Inc | GBA | 2019-10-17 |
| 00678467506337 | Mui Scientific | H & A Mui Enterprises Inc | GBA | 2019-10-17 |
| 00678467506610 | Mui Scientific | H & A Mui Enterprises Inc | GBA | 2019-10-17 |
| 00678467001450 | Mui Scientific | H & A Mui Enterprises Inc | GBA | 2019-10-16 |
| 00678467001627 | Mui Scientific | H & A Mui Enterprises Inc | GBA | 2019-10-16 |
| 00678467001894 | Mui Scientific | H & A Mui Enterprises Inc | GBA | 2019-10-16 |
| 00678467001924 | Mui Scientific | H & A Mui Enterprises Inc | GBA | 2019-10-16 |
| 00678467002150 | Mui Scientific | H & A Mui Enterprises Inc | GBA | 2019-10-16 |
| 00678467002358 | Mui Scientific | H & A Mui Enterprises Inc | GBA | 2019-10-16 |
| 00678467002426 | Mui Scientific | H & A Mui Enterprises Inc | GBA | 2019-10-16 |
| 00678467002549 | Mui Scientific | H & A Mui Enterprises Inc | GBA | 2019-10-16 |
| 00678467002600 | Mui Scientific | H & A Mui Enterprises Inc | GBA | 2019-10-16 |
| 00678467002655 | Mui Scientific | H & A Mui Enterprises Inc | GBA | 2019-10-16 |