UNIVERSAL F® X001

GUDID 00612649128870

UNIVERSAL F EXTENSION SET

King Systems Corporation

Anaesthesia breathing circuit, single-use
Primary Device ID00612649128870
NIH Device Record Key63f59440-eb89-4b29-97cb-65a433603744
Commercial Distribution StatusIn Commercial Distribution
Brand NameUNIVERSAL F®
Version Model NumberX001
Catalog NumberX001
Company DUNS009299017
Company NameKing Systems Corporation
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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 Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(410)768-6464
EmailPurchase_orders@ambuUSA.com
Phone+1(410)768-6464
EmailPurchase_orders@ambuUSA.com
Phone+1(410)768-6464
EmailPurchase_orders@ambuUSA.com
Phone+1(410)768-6464
EmailPurchase_orders@ambuUSA.com
Phone+1(410)768-6464
EmailPurchase_orders@ambuUSA.com
Phone+1(410)768-6464
EmailPurchase_orders@ambuUSA.com
Phone+1(410)768-6464
EmailPurchase_orders@ambuUSA.com
Phone+1(410)768-6464
EmailPurchase_orders@ambuUSA.com
Phone+1(410)768-6464
EmailPurchase_orders@ambuUSA.com
Phone+1(410)768-6464
EmailPurchase_orders@ambuUSA.com
Phone+1(410)768-6464
EmailPurchase_orders@ambuUSA.com
Phone+1(410)768-6464
EmailPurchase_orders@ambuUSA.com

Device Dimensions

Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS100612649128870 [Package]
Contains: 00612649208039
Package: [30 Units]
In Commercial Distribution
GS100612649208039 [Primary]

FDA Product Code

CAICircuit, breathing (w connector, adaptor, y piece)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2026-01-30
Device Publish Date2022-12-13

On-Brand Devices [UNIVERSAL F®]

00612649128825UNIVERSAL F TRANSPORT KIT
00612649128108UNIVERSAL F CIRCUIT
00612649128054UNIVERSAL F CIRCUIT
00612649128603UNIVERSAL F CIRCUIT
00612649170510UNIVERSAL F CIRCUIT
00612649211077UNIVERSAL F CIRCUIT
00612649128894UNIVERSAL F EXTENSION SET
00612649128870UNIVERSAL F EXTENSION SET
00612649184067UNIVERSAL F CIRCUIT
00612649128016UNIVERSAL F CIRCUIT

Trademark Results [UNIVERSAL F]

Mark Image

Registration | Serial
Company
Trademark
Application Date
UNIVERSAL F
UNIVERSAL F
74475379 1884793 Live/Registered
KING SYSTEMS CORPORATION
1994-01-03
UNIVERSAL F
UNIVERSAL F
74323503 not registered Dead/Abandoned
King Systems- Division of Burco Molding, Inc.
1992-10-19

© 2026 FDA.report
This site is not affiliated with or endorsed by the FDA.