FDA.reportPublic FDA data

InHealth Technologies; Blom-Singer

Primary DI
00848253003412
Brand
InHealth Technologies; Blom-Singer
Company
Freudenberg Medical, LLC
Model
PK 2102
Device description
Post-Operative Care Kit with 9/55 Tube & EasyFlow HME
Published
2019-06-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
BYDCondenser, Heat And Moisture (Artificial Nose)
CBHDevice, Fixation, Tracheal Tube
EWLProsthesis, Laryngeal (Taub)
KACTube, Laryngectomy
KGXTape And Bandage, Adhesive

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BYDCondenser, Heat And Moisture (Artificial Nose)Anesthesiology1
CBHDevice, Fixation, Tracheal TubeAnesthesiology1
EWLProsthesis, Laryngeal (Taub)Ear, Nose, Throat2
KACTube, LaryngectomyEar, Nose, Throat1
KGXTape And Bandage, AdhesiveGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00848253003412PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00848253003412008482530034128482530034120848253003412

GMDN Terms#

Term, Definition table
TermDefinition
Tracheostoma shower shieldA non-sterile, waterproof, patient-worn device intended to cover a tracheal stoma or tracheostomy tube to prevent inhalation of water during showering. It is typically in the form of a waterproof bib worn around the patient’s neck. This is a reusable device intended for single-patient use.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
120981337
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00848253003634InHealth Technologies; Blom-SingerPK 21062019-07-10
00848253003641InHealth Technologies; Blom-SingerPK 21072019-07-10
00848253003399InHealth Technologies; Blom-SingerPK 21002019-06-07
00848253003405InHealth Technologies; Blom-SingerPK 21012019-06-07
00848253003429InHealth Technologies; Blom-SingerPK 21032019-06-07
00848253003436InHealth Technologies; Blom-SingerPK 21042019-06-07
00848253003443InHealth Technologies; Blom-SingerPK 21052019-06-07
00813307012597InHealth Technologies; Blom-SingerBE 60452018-01-01
00813307012603InHealth Technologies; Blom-SingerBE 60462018-01-01
00813307012634InHealth Technologies; Blom-SingerBE 60412018-01-01
00813307012641InHealth Technologies; Blom-SingerBE 60422018-01-01
00813307012658InHealth Technologies; Blom-SingerBE 60432018-01-01
00813307012665InHealth Technologies; Blom-SingerBE 60442018-01-01
00813307012672InHealth Technologies; Blom-SingerBE 60342018-01-01
00813307012689InHealth Technologies; Blom-SingerBE 60352018-01-01
00813307012740InHealth Technologies; Blom-SingerBE 60482016-09-24
00198715836998EMPOWER™ INTRODUCER SHEATH WITH HYDROPHILIC COATING668782-101PN1007960-1002026-01-29
00848253004037StomaSoft Cleaning SwabsTSWB10TSWB102025-03-17
00848253003955TruFit™ Adhesive Housing, 6 PackBE 6088-62025-04-01
00848253003931TruFit™ Adhesive Housing, 30 PackBE 60882025-04-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
09420012436047Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDKGX2026-04-14
09420012436061Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDKGX2026-04-14
08904428744916OSSEOUS- ShowerProtectEON MEDITECH PRIVATE LIMITEDBYD2026-03-13
08904428744947OSSEOUS- NeckFit Tube HolderEON MEDITECH PRIVATE LIMITEDCBH2026-03-13
08904428745067OSSEOUS- TouchFree HME Series - StandardEON MEDITECH PRIVATE LIMITEDBYD2026-03-13
08904461000499OSSEOUS-Heat Moisture Exchanger-AirEON MEDITECH PRIVATE LIMITEDBYD2026-03-13
10080196669523MEDLINEMEDLINE INDUSTRIES, INC.KGX2026-01-30
10080196669530MEDLINEMEDLINE INDUSTRIES, INC.KGX2026-01-30
10080196669547MEDLINEMEDLINE INDUSTRIES, INC.KGX2026-01-30
10192253044591ArgyleCardinal Health 200, LLCCBH2025-08-26
10080196691708CURADMEDLINE INDUSTRIES, INC.KGX2025-05-23
10080196669417MEDLINEMEDLINE INDUSTRIES, INC.KGX2024-07-31
10080196669493MEDLINEMEDLINE INDUSTRIES, INC.KGX2024-07-31
10080196743032MEDLINEMEDLINE INDUSTRIES, INC.KGX2024-07-31
09355751001259Seer HomeSEER MEDICAL HOLDINGS LIMITEDKGX2024-06-27
08904428723706OSSEOUSEON MEDITECH PRIVATE LIMITEDKAC2024-06-12
08904428723713OSSEOUSEON MEDITECH PRIVATE LIMITEDKAC2024-06-12
08904428723720OSSEOUSEON MEDITECH PRIVATE LIMITEDKAC2024-06-12
08904428723737OSSEOUSEON MEDITECH PRIVATE LIMITEDKAC2024-06-12
08904428723744OSSEOUSEON MEDITECH PRIVATE LIMITEDKAC2024-06-12
08904428723751OSSEOUSEON MEDITECH PRIVATE LIMITEDKAC2024-06-12
08904428723768OSSEOUSEON MEDITECH PRIVATE LIMITEDKAC2024-06-12
08904428723775OSSEOUSEON MEDITECH PRIVATE LIMITEDKAC2024-06-12
08904428723782OSSEOUSEON MEDITECH PRIVATE LIMITEDKAC2024-06-12
08904428723799OSSEOUSEON MEDITECH PRIVATE LIMITEDKAC2024-06-12
08904428723805OSSEOUSEON MEDITECH PRIVATE LIMITEDKAC2024-06-12
08904428723812OSSEOUSEON MEDITECH PRIVATE LIMITEDKAC2024-06-12
08906039312010OSSEOUSEON MEDITECH PRIVATE LIMITEDKAC2024-06-12
08906039312027OSSEOUSEON MEDITECH PRIVATE LIMITEDKAC2024-06-12
08906039312034OSSEOUSEON MEDITECH PRIVATE LIMITEDKAC2024-06-12