FDA.report

CUSTOM ACCESSORY

Primary DI
00612649200637
Brand
CUSTOM ACCESSORY
Company
King Systems Corporation
Model
D074
Catalog number
D074
Device description
CUSTOM ACCESSORY
Published
2022-12-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
BYXTUBING, PRESSURE AND ACCESSORIES

Product Code Classifications

CodeDeviceSpecialtyClass
BYXTubing, Pressure And AccessoriesAnesthesiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00612649171432PackageGS120In Commercial Distribution
00612649200637PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00612649171432006126491714326126491714320612649171432
00612649200637006126492006376126492006370612649200637

GMDN Terms

TermDefinition
Anaesthesia breathing circuit, single-useAn assembly of devices designed to conduct medical gases from an anaesthesia unit/workstation to a patient artificial airway/anaesthesia mask (not included) during general anaesthesia. It includes breathing tubes and a Y-piece connector, typically with a ventilator/ventilation bag and appropriate connectors, and may include a carbon dioxide (CO2) absorber, a one-way directional valve, or adjustable pressure limiting (APL) valve. This is a single-use device.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(410)768-6464Purchase_orders@ambuUSA.com

Regulatory Flags

DUNS number
009299017
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00612649214559UNIVERSAL F® FLEX2®AF476-6121ZAF476-6121Z2023-01-18
00612649100494CORRUGATED TUBING1011001011002022-12-18
00612649185224WASHINGTON CONNECTOR178517852022-12-08
00612649106779100 FT 22MM ULTRA FLEX® TUBING30010300102022-12-18
00612649121758100 FT., 6" 22MM SEGMENTEDB101100B1011002022-12-08
00612649149103RE'SPOSABLE® F2®MD121MD1212022-12-08
0061264915411418" REUSABLE TUBINGMD124MD1242022-12-08
00612649190242BREATHING BAG514551452022-12-08
00612649190181BREATHING BAG513751372022-12-08
00612649190211BREATHING BAG514151412022-12-08
00612649190198BREATHING BAG513951392022-12-08
00612649190136BREATHING BAG510951092022-12-08
00612649190112BREATHING BAG510751072022-12-08
00612649190105BREATHING BAG510551052022-12-08
00612649190129BREATHING BAG510851082022-12-08
00612649190099BREATHING BAG510151012022-12-08
00612649190068BREATHING BAG509750972022-12-08
00612649190075BREATHING BAG509850982022-12-08
00612649190082BREATHING BAG509950992022-12-08
00612649190044BREATHING BAG509450942022-12-08

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