FDA.reportPublic FDA data

Uni-Lim™

Primary DI
20889483300258
Brand
Uni-Lim™
Company
SUNMED, LLC
Model
R-6884
Catalog number
R-6884
Device description
Uni-Lim™ Coaxial Circuit 72" (183 cm) Adult Coaxial Circle Anesthesia Circuit, Gas Sampling Elbow
Published
2025-12-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
CAICircuit, Breathing (W Connector, Adaptor, Y Piece)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CAICircuit, Breathing (W Connector, Adaptor, Y Piece)Anesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20889483300258PackageGS120In Commercial Distribution
10889483612040PreviousGS10
10889483300251PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088948330025820889483300258
1088948361204010889483612040
1088948330025110889483300251

GMDN Terms#

Term, Definition table
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 table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-433-2797info@sun-med.com

Regulatory Flags#

DUNS number
069009268
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10889483222065VixOne™020502052025-12-19
10889483224533VixOne™022302232025-12-19
10889483230046VixOne™032503252025-12-19
10889483231234VixOne™023302332025-12-19
10889483495742Pedi-Neb™3655PN-6123655PN-6122025-12-19
10889483002742Mask Harness4-1054-222026-03-19
30889483631472AirLifeFC0010FC00102026-02-27
20889483033309SunMed09-0203-0609-0203-062026-02-18
20889483033316SunMed09-0203-1009-0203-102026-02-18
20889483033323SunMed09-0203-1409-0203-142026-02-18
20889483230005VixOne™031103112026-02-11
20889483300135Respan®R-8270R-82702026-02-11
30889483562615BALLARD™227-5227-52025-11-21
30889483563391BALLARD™12601126012025-11-19
30889483563681BALLARD™196812718681272025-11-19
30889483563711BALLARD™197812719781272025-11-19
30889483567030BALLARD™821582152025-11-19
30889483623316BALLARD™21603-4J21603-4J2025-11-21
30889483623323BALLARD™216036-4J216036-4J2025-11-21
30889483623347BALLARD™2160-4J2160-4J2025-11-21

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Primary DI, Brand, Company table
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20889483300135Respan®SUNMED, LLCCAI2026-02-11
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