FDA.reportPublic FDA data

InHealth Technologies; Blom-Singer

Primary DI
00848253001807
Brand
InHealth Technologies; Blom-Singer
Company
Freudenberg Medical, LLC
Model
SP 2133
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LFBButton, Nasal Septal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LFBButton, Nasal SeptalUnknownU

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00848253001807PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00848253001807008482530018078482530018070848253001807

GMDN Terms#

Term, Definition table
TermDefinition
Nasal septal buttonA device that is implanted to occlude a perforation in the nasal septum. It typically consists of a central post and two flanged ends. The device is inserted into a nostril, one leaf is folded and placed through the septum perforation, grasped through the opposite nostril and secured closing the perforation. It is used to improve nasal respiration.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Not to exceed 66C

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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00763000886721N/AMEDTRONIC XOMED, INC.LFB2025-06-23
00763000886738N/AMEDTRONIC XOMED, INC.LFB2025-06-23
34063107102258Nasal Septal ButtonBoston Medical Products, Inc.LFB2022-09-29
10385640065204SUMMIT MEDICALSUMMIT MEDICAL, INC.LFB2021-06-18
10385640065211SUMMIT MEDICALSUMMIT MEDICAL, INC.LFB2021-06-18
10385640065228SUMMIT MEDICALSUMMIT MEDICAL, INC.LFB2021-06-18
00813307013013InHealth Technologies; Blom-SingerFreudenberg Medical, LLCLFB2020-05-13
00813307013082InHealth Technologies; Blom-SingerFreudenberg Medical, LLCLFB2020-05-13
00848253002101InHealth Technologies; Blom-SingerFreudenberg Medical, LLCLFB2020-05-13
00848253002118InHealth Technologies; Blom-SingerFreudenberg Medical, LLCLFB2020-05-13
00848253002125InHealth Technologies; Blom-SingerFreudenberg Medical, LLCLFB2020-05-13
00848253002132InHealth Technologies; Blom-SingerFreudenberg Medical, LLCLFB2020-05-13
00848253002149InHealth Technologies; Blom-SingerFreudenberg Medical, LLCLFB2020-05-13
00848253002156InHealth Technologies; Blom-SingerFreudenberg Medical, LLCLFB2020-05-13
00848253002163InHealth Technologies; Blom-SingerFreudenberg Medical, LLCLFB2020-05-13
00848253002170InHealth Technologies; Blom-SingerFreudenberg Medical, LLCLFB2020-05-13
00848253002187InHealth Technologies; Blom-SingerFreudenberg Medical, LLCLFB2020-05-13
00848253002194InHealth Technologies; Blom-SingerFreudenberg Medical, LLCLFB2020-05-13
00763000035686N/AMEDTRONIC XOMED, INC.LFB2020-04-19
00763000035693N/AMEDTRONIC XOMED, INC.LFB2020-04-19
00763000036119N/AMEDTRONIC XOMED, INC.LFB2020-04-19
00681490041935NAMEDTRONIC XOMED, INC.LFB2017-03-11
00681490041942NAMEDTRONIC XOMED, INC.LFB2017-03-11
00681490195317NAMEDTRONIC XOMED, INC.LFB2017-03-11
00681490195331NAMEDTRONIC XOMED, INC.LFB2017-03-11
00681490195348NAMEDTRONIC XOMED, INC.LFB2017-03-11
00818501020010Invotec Nasal Septal ButtonINVOTEC INTERNATIONAL, INC.LFB2017-01-03
00818501020003Invotec Nasal Septal ButtonINVOTEC INTERNATIONAL, INC.LFB2016-12-31
00848253001715InHealth Technologies; Blom-SingerFreudenberg Medical, LLCLFB2016-09-24
00848253001722InHealth Technologies; Blom-SingerFreudenberg Medical, LLCLFB2016-09-24