FDA.reportPublic FDA data

Control-Cric

Primary DI
10841470109063
Brand
Control-Cric
Company
PULMODYNE INC
Model
313-4567
Published
2021-09-30
Public version status
New
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 table
CodeName
BTOTube, Tracheostomy (W/Wo Connector)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BTOTube, Tracheostomy (W/Wo Connector)Anesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K830509000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K830509000EMERGENCY TRACHEOSTOMY & CRICOTHYROIDO-Frederic J. Toye, M.D.1983-03-29BTO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10841470109063PackageGS15In Commercial Distribution
00841470109066PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084147010906310841470109063
00841470109066008414701090668414701090660841470109066

GMDN Terms#

Term, Definition table
TermDefinition
Cricothyrotomy kit, single-useA collection of sterile devices designed to perform a cricothyrotomy (an incision through the skin and cricothyroid) providing airway access within seconds allowing for immediate ventilation of the patient and necessary suction procedures. It is used to open a patient's airway in emergency interventions, e.g., accidental blockage to the upper airway tract, and prior to tracheostomy. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
030619483
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
00841470100841Percussor313-41962026-05-29
00841470100858Percussor313-41972026-05-29
00841470104740BiTrac Select313-95892025-09-30
00841470104764BiTrac Select313-95912025-09-30
00841470100148O2-MAX313-8201-62025-04-12
00841470105501BiTrac101615782025-04-11
00841470105518BiTrac 101615772025-04-11
00841470105525BiTrac101615792025-04-11
00841470105532BiTrac101615762025-04-11
00841470105549BiTrac 101600492025-04-11
00841470105556BiTrac 101600502025-04-11
00841470105563BiTrac 101600512025-04-11
00841470105570BiTrac 101600522025-04-11
00841470105587BiTrac SE101600532025-04-11
00841470105594BiTrac SE101600542025-04-11
00841470105600BiTrac SE101600552025-04-11
00841470105617BiTrac SE101600562025-04-11
00841470105631BiTrac Select101617662025-04-11
00841470105648BiTrac Select101617672025-04-11
00841470105655BiTrac Select101617682025-04-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10192253071894ArgyleCardinal Health 200, LLCBTO2026-07-13
15019517382860ICU Medical, Inc.ICU MEDICAL, INC.BTO2026-07-06
00348783010640Premier Jackson Original Tracheostomy TubePREMIER DENTAL PRODUCTS COMPANYBTO2026-06-09
00348783010657Premier Jackson Original Tracheostomy TubePREMIER DENTAL PRODUCTS COMPANYBTO2026-06-09
00348783010664Premier Jackson Original Tracheostomy TubePREMIER DENTAL PRODUCTS COMPANYBTO2026-06-09
00348783010671Premier Jackson Original Tracheostomy TubePREMIER DENTAL PRODUCTS COMPANYBTO2026-06-09
00348783010695Premier Jackson Original Tracheostomy TubePREMIER DENTAL PRODUCTS COMPANYBTO2026-06-09
00348783010701Premier Jackson Original Tracheostomy TubePREMIER DENTAL PRODUCTS COMPANYBTO2026-06-09
00348783010718Premier Jackson Original Tracheostomy TubePREMIER DENTAL PRODUCTS COMPANYBTO2026-06-09
00348783010725Premier Jackson Original Tracheostomy TubePREMIER DENTAL PRODUCTS COMPANYBTO2026-06-09
00348783010732Premier Jackson Original Tracheostomy TubePREMIER DENTAL PRODUCTS COMPANYBTO2026-06-09
00348783010749Premier Jackson Original Tracheostomy TubePREMIER DENTAL PRODUCTS COMPANYBTO2026-06-09
00348783010756Premier Jackson Original Tracheostomy TubePREMIER DENTAL PRODUCTS COMPANYBTO2026-06-09
00348783010770Premier Jackson Improved Tracheostomy TubePREMIER DENTAL PRODUCTS COMPANYBTO2026-06-09
00348783010787Premier Jackson Improved Tracheostomy TubePREMIER DENTAL PRODUCTS COMPANYBTO2026-06-09
00348783010794Premier Jackson Improved Tracheostomy TubePREMIER DENTAL PRODUCTS COMPANYBTO2026-06-09
00348783010800Premier Jackson Improved Tracheostomy TubePREMIER DENTAL PRODUCTS COMPANYBTO2026-06-09
00348783010817Premier Jackson Improved Tracheostomy TubePREMIER DENTAL PRODUCTS COMPANYBTO2026-06-09
00348783010824Premier Jackson Improved Tracheostomy TubePREMIER DENTAL PRODUCTS COMPANYBTO2026-06-09
00348783010831Premier Jackson Improved Tracheostomy TubePREMIER DENTAL PRODUCTS COMPANYBTO2026-06-09
00348783010848Premier Jackson Improved Tracheostomy TubePREMIER DENTAL PRODUCTS COMPANYBTO2026-06-09
00348783010855Premier Jackson Improved Tracheostomy TubePREMIER DENTAL PRODUCTS COMPANYBTO2026-06-09
00348783010862Premier Jackson Improved Tracheostomy TubePREMIER DENTAL PRODUCTS COMPANYBTO2026-06-09
00348783010879Premier Jackson Improved Tracheostomy TubePREMIER DENTAL PRODUCTS COMPANYBTO2026-06-09
00348783010886Premier Jackson Improved Tracheostomy TubePREMIER DENTAL PRODUCTS COMPANYBTO2026-06-09
00348783010893Premier Jackson Improved Tracheostomy TubePREMIER DENTAL PRODUCTS COMPANYBTO2026-06-09
00348783010909Premier Jackson Improved Tracheostomy TubePREMIER DENTAL PRODUCTS COMPANYBTO2026-06-09
00348783010916Premier Jackson Improved Tracheostomy TubePREMIER DENTAL PRODUCTS COMPANYBTO2026-06-09
00348783010923Premier Jackson Improved Tracheostomy TubePREMIER DENTAL PRODUCTS COMPANYBTO2026-06-09
00348783010930Premier Jackson Improved Tracheostomy TubePREMIER DENTAL PRODUCTS COMPANYBTO2026-06-09