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

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Primary DI, Brand, Company table
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10192253052916ArgyleCardinal Health 200, LLCBTO2024-02-16
10192253052923ArgyleCardinal Health 200, LLCBTO2024-02-16
10192253052930ArgyleCardinal Health 200, LLCBTO2024-02-16
10192253052954ArgyleCardinal Health 200, LLCBTO2024-02-16
10192253052978ArgyleCardinal Health 200, LLCBTO2024-02-16
10192253052985ArgyleCardinal Health 200, LLCBTO2024-02-16
10192253052992ArgyleCardinal Health 200, LLCBTO2024-02-16
14063107100571Montgomery® Short-Term CannulaBoston Medical Products, Inc.BTO2022-09-30
14063107100588Montgomery® Long-Term CannulaBoston Medical Products, Inc.BTO2022-09-30
14063107100595Montgomery® Long-Term CannulaBoston Medical Products, Inc.BTO2022-09-30
14063107100601Montgomery® Long-Term CannulaBoston Medical Products, Inc.BTO2022-09-30
14063107100618Montgomery® Long-Term CannulaBoston Medical Products, Inc.BTO2022-09-30
14026704646699RUSCHTELEFLEX INCORPORATEDBTO2019-07-01
14026704646705RUSCHTELEFLEX INCORPORATEDBTO2019-07-01
M6898250001010Mojo RFR First Responder SetSafeguard US Operating, LLCBTO2018-06-04
M6898260001010Mojo RFR Airway & Respiration SetSafeguard US Operating, LLCBTO2018-06-04
10884521751354ShileyCovidien LPBTO2018-02-06
10884521751361ShileyCovidien LPBTO2018-02-06
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