InHealth Technologies; Blom-Singer
- Primary DI
- 00848253000954
- Brand
- InHealth Technologies; Blom-Singer
- Company
- Freudenberg Medical, LLC
- Model
- FM 1004
- Published
- 2017-01-01
- 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 |
|---|
| LRC | Instrument, Ent Manual Surgical |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| LRC | Instrument, Ent Manual Surgical | Ear, Nose, Throat | 1 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 00848253000954 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|
| 00848253000954 | 00848253000954 | 848253000954 | 0848253000954 |
GMDN Terms
| Term | Definition |
|---|
| Hypopharyngeal fistula occluder | A sterile device intended to be used for the non-surgical short-term (i.e., < 30 days) occlusion of a fistula in the upper end of the oesophagus (hypopharynx), typically where the fistula has an external opening, to prevent leakage of oesophageal content. It consists of two disk-like flanges (one being positioned on the inside of the pharynx and one on the outside) attached to a single- or double-beaded stem, and is made of silicone and plastic materials. It is inserted and removed using a dedicated device. This is a single-use device. |
Regulatory Flags
- DUNS number
- 120981337
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- false
- 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
- false
- Sterilization required before use
- false
Other Devices From This Company
| Primary DI | Brand | Model | Catalog | Published |
|---|
| 00198715836998 | EMPOWER™ INTRODUCER SHEATH WITH HYDROPHILIC COATING | 668782-101 | PN1007960-100 | 2026-01-29 |
| 00848253003948 | TruFit™ Adhesive Housing, 30 Pack | BE 6088 | | 2025-04-01 |
| 00848253003931 | TruFit™ Adhesive Housing, 6 Pack | BE 6088-6 | | 2025-04-01 |
| 00848253004013 | Cleaning Brush, Standard | IN 4062 | IN 4062 | 2025-03-25 |
| 00848253004020 | Cleaning Brush, Long | IN 4063 | IN 4063 | 2025-03-25 |
| 00848253004037 | StomaSoft Cleaning Swabs | TSWB10 | SPT 002 | 2025-03-17 |
| 00848253004006 | Blom-Singer® Nasal Septal Perforation Sizing Tool | SPT 002 | SPT 002 | 2025-03-14 |
| 00848253002347 | InHealth Technologies; Blom-Singer | TP 1608 | | 2023-11-03 |
| 00848253002354 | InHealth Technologies; Blom-Singer® | TP 1610 | | 2023-11-03 |
| 00848253002361 | InHealth Technologies; Blom-Singer® | TP 1612 | | 2023-11-03 |
| 00848253002378 | InHealth Technologies; Blom-Singer® | TP 1614 | | 2023-11-03 |
| 00848253002385 | InHealth Technologies; Blom-Singer® | TP 2008 | | 2023-11-03 |
| 00848253002408 | InHealth Technologies; Blom-Singer® | TP 2010 | | 2023-11-03 |
| 00848253002606 | InHealth Technologies; Blom-Singer® | TP 2012 | | 2023-11-03 |
| 00848253003092 | InHealth Technologies; Blom-Singer® | TP 2014 | | 2023-11-03 |
| 00848253003115 | InHealth Technologies; Blom-Singer® | TP 2208-LEF | | 2023-11-03 |
| 00848253003122 | InHealth Technologies; Blom-Singer® | TP 2210-LEF | | 2023-11-03 |
| 00848253003139 | InHealth Technologies; Blom-Singer® | TP 2212-LEF | | 2023-11-03 |
| 00850004312001 | EMPOWER™ INTRODUCER SHEATH WITH HYDROPHILIC COATING | 668782-100 | PN1007960-100 | 2021-06-15 |
| 00848253003665 | InHealth Technologies | VP 2206-LEF | | 2021-02-03 |
Other Devices Sharing Product Codes
inhealth.com