Infant Resuscitation Kit. T-Piece Circuit

GUDID 05055931119623

1.8m (70") Oxygen Line 2.1m (82") Round Masks Sizes 0 + 1

FLEXICARE MEDICAL LIMITED

Ventilator breathing circuit, single-use
Primary Device ID05055931119623
NIH Device Record Keye691f92e-80da-4e2c-9707-90b9750ca8b0
Commercial Distribution StatusIn Commercial Distribution
Brand NameInfant Resuscitation Kit. T-Piece Circuit
Version Model NumberNF-155U
Company DUNS504406273
Company NameFLEXICARE MEDICAL LIMITED
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS105055931119623 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

BYEAttachment, Breathing, Positive End Expiratory Pressure

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-08-04
Device Publish Date2023-07-27

On-Brand Devices [Infant Resuscitation Kit. T-Piece Circuit]

008544010065631.8m (70") Oxygen Line 2.1m (82") and Round Masks Size 1
008544010065491.8m (70") Oxygen Line 2.1m (82") and Round Masks Size 0
008544010065251.8m (70") with Anatomical Mask Size 1
008544010064881.8m (70") Oxygen Line 2.1m (82") Anatomical Mask Size 0
008544010064571.8m (70") Oxygen Line  2.1m (82") Anatomical Masks 0 + 1
008544010064401.8m (70") with Anatomical Masks Sizes 0 + 1
008544010064331.8m (70") Oxygen Line 2.1m (82") Round Masks Sizes 0 + 1
008544010064261.8m (70") with Round Masks Sizes 0 + 1
008544010063721.8m (70") Oxygen Line 2.1m (82") Catheter Access Adapter
050559311196921.8m (70") Oxygen Line 2.1m (82") and Round Masks Size 1
050559311196851.8m (70") Oxygen Line 2.1m (82") and Round Masks Size 0
050559311196781.8m (70") with Anatomical Mask Size 1
050559311196541.8m (70") Oxygen Line 2.1m (82") Anatomical Mask Size 0
05055931119647NF-156U
050559311196301.8m (70") with Anatomical Masks Sizes 0 + 1
050559311196231.8m (70") Oxygen Line 2.1m (82") Round Masks Sizes 0 + 1
050559311196161.8m (70") with Round Masks Sizes 0 + 1
050559311195791.8m (70") Oxygen Line 2.1m (82") Catheter Access Adapter

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