Ambu Cuff Pressure Gauge 321900000

GUDID 05707480133086

Ambu Cuff Pressure Gauge, for inflating and testing cuffs Tube length 100 cm, luer type connection

Ambu A/S

Endotracheal tube cuff inflator
Primary Device ID05707480133086
NIH Device Record Key26ebd95e-7b78-4455-9e64-61b34f45866e
Commercial Distribution StatusIn Commercial Distribution
Brand NameAmbu Cuff Pressure Gauge
Version Model Number321900000
Catalog Number321900000
Company DUNS305682023
Company NameAmbu A/S
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 Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+14107686464
EmailPurchase_orders@ambuUSA.com
Phone+14107686464
EmailPurchase_orders@ambuUSA.com
Phone+14107686464
EmailPurchase_orders@ambuUSA.com
Phone+14107686464
EmailPurchase_orders@ambuUSA.com
Phone+14107686464
EmailPurchase_orders@ambuUSA.com
Phone+14107686464
EmailPurchase_orders@ambuUSA.com
Phone+14107686464
EmailPurchase_orders@ambuUSA.com
Phone+14107686464
EmailPurchase_orders@ambuUSA.com
Phone+14107686464
EmailPurchase_orders@ambuUSA.com
Phone+14107686464
EmailPurchase_orders@ambuUSA.com
Phone+14107686464
EmailPurchase_orders@ambuUSA.com
Phone+14107686464
EmailPurchase_orders@ambuUSA.com
Phone+14107686464
EmailPurchase_orders@ambuUSA.com
Phone+14107686464
EmailPurchase_orders@ambuUSA.com
Phone+14107686464
EmailPurchase_orders@ambuUSA.com

Device Identifiers

Device Issuing AgencyDevice ID
GS105707480133079 [Primary]
GS105707480133086 [Package]
Contains: 05707480133079
Package: [42 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

BSKCuff, tracheal tube, inflatable

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-03-21
Device Publish Date2016-09-20

Devices Manufactured by Ambu A/S

05707480157136 - Ambu® aScope™ Duodeno 22024-07-29 Duodenoscope
05707480006540 - Immobilization Kit, with2024-07-22 Ambu® Perfit ACE™ and Ambu® Head Wedge™, Adult
05707480006557 - Immobilization Kit, with2024-07-22 Ambu® Mini Perfit ACE™ and Ambu® Head Wedge™, Small Pediatric and Pediatric
05707480037308 - Immobilization Kit, with2024-07-22 Ambu® Perfit ACE™ and Ambu® Head Wedge™, Adult
05707480038626 - Immobilization Kit, with2024-07-22 Ambu® Military Perfit ACE™ and Ambu® Military Head Wedge™, Adult
05707480006601 - Silicone Face Mask2024-07-16 Reusable face mask
05707480006625 - Silicone Face Mask2024-07-16 Reusable face mask
05707480006632 - Silicone Face Mask2024-07-16 Reusable face mask

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.