FDA.reportPublic FDA data

InHealth Technologies; Blom-Singer

Primary DI
00848253000947
Brand
InHealth Technologies; Blom-Singer
Company
Freudenberg Medical, LLC
Model
FM 1003
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
LRCInstrument, Ent Manual Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LRCInstrument, Ent Manual SurgicalEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00848253000947PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00848253000947008482530009478482530009470848253000947

GMDN Terms#

Term, Definition table
TermDefinition
Hypopharyngeal fistula occluderA 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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800-477-5969InHealth@inhealth.com

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 table
Primary DIBrandModelCatalogPublished
00198715836998EMPOWER™ INTRODUCER SHEATH WITH HYDROPHILIC COATING668782-101PN1007960-1002026-01-29
00848253003948TruFit™ Adhesive Housing, 30 PackBE 60882025-04-01
00848253003931TruFit™ Adhesive Housing, 6 PackBE 6088-62025-04-01
00848253004013Cleaning Brush, StandardIN 4062IN 40622025-03-25
00848253004020Cleaning Brush, LongIN 4063IN 40632025-03-25
00848253004037StomaSoft Cleaning SwabsTSWB10SPT 0022025-03-17
00848253004006Blom-Singer® Nasal Septal Perforation Sizing ToolSPT 002SPT 0022025-03-14
00848253002347InHealth Technologies; Blom-SingerTP 16082023-11-03
00848253002354InHealth Technologies; Blom-Singer®TP 16102023-11-03
00848253002361InHealth Technologies; Blom-Singer®TP 16122023-11-03
00848253002378InHealth Technologies; Blom-Singer®TP 16142023-11-03
00848253002385InHealth Technologies; Blom-Singer®TP 20082023-11-03
00848253002408InHealth Technologies; Blom-Singer®TP 20102023-11-03
00848253002606InHealth Technologies; Blom-Singer®TP 20122023-11-03
00848253003092InHealth Technologies; Blom-Singer®TP 20142023-11-03
00848253003115InHealth Technologies; Blom-Singer®TP 2208-LEF2023-11-03
00848253003122InHealth Technologies; Blom-Singer®TP 2210-LEF2023-11-03
00848253003139InHealth Technologies; Blom-Singer®TP 2212-LEF2023-11-03
00850004312001EMPOWER™ INTRODUCER SHEATH WITH HYDROPHILIC COATING668782-100PN1007960-1002021-06-15
00848253003665InHealth TechnologiesVP 2206-LEF2021-02-03

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Primary DI, Brand, Company table
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09348811102638INKAThe Trustee for KAISER FAMILY TRUSTLRC2026-01-28
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00198506088070ELMED INCORPORATEDELMED INCORPORATEDLRC2026-01-23
00198506087813ELMED INCORPORATEDELMED INCORPORATEDLRC2026-01-16