FDA.reportPublic FDA data

Gyrus ACMI

Primary DI
00821925007321
Brand
Gyrus ACMI
Company
Gyrus ACMI, LLC
Model
75U
Device description
Universal Stopcock Adapter Luer Lock
Published
2018-09-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
CCWLARYNGOSCOPE, RIGID

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CCWLaryngoscope, RigidAnesthesiology1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K883819000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K883819000BULLARD INTUBATING LARYNGOSCOPE LAR-A & LAR-PCircon Acmi1988-10-17CCW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00821925007321PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00821925007321008219250073218219250073210821925007321

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic biopsy valve, single-useA device intended to be fitted to an endoscope biopsy port to enable access for/exchange of endoscopic devices while maintaining insufflation and minimizing leakage of biomaterial during an endoscopic procedure. It is typically in the form of a small attachment with an elastomer seal; it may include a water input valve for simultaneous irrigation/biopsy. This is a single-use device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
007198742
Device count
1
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00821925012738EVONOS GMBH & Co. Kg1300152018-09-04
00821925012783EVONOS1300202018-09-06
00821925012790EVONOS130021-ENT2018-09-06
00821925012806EVONOS1300222018-09-06
00821925012813EVONOS1300232018-09-06
00821925012820EVONOS1300242018-09-06
00821925012837Gyrus ACMI130025-ENT2018-09-06
00821925012929EVONOS1300382018-09-06
00821925013001EVONOS1302012018-09-10
00821925013018EVONOS1302022018-09-10
00821925013025EVONOS1302032018-09-10
00821925013032EVONOS1302042018-09-10
00821925013155EVONOS1302432018-09-10
00821925013285EVONOS1301352018-09-07
00821925013292EVONOS1301362018-09-07
00821925013308EVONOS1301372018-09-07
00821925013315EVONOS1301382018-09-07
00821925013612EVONOS1303132018-09-10
00821925013629EVONOS1303162018-09-10
00821925013827EVONOS1303652018-09-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06971355350147BESDATAShenzhen BesdataTechnology Co., LTD.CCW2026-09-04
06971355350154BESDATAShenzhen BesdataTechnology Co., LTD.CCW2026-09-04
06971355350161BESDATAShenzhen BesdataTechnology Co., LTD.CCW2026-09-04
06971355350178BESDATAShenzhen BesdataTechnology Co., LTD.CCW2026-09-04
06971355350512BESDATAShenzhen BesdataTechnology Co., LTD.CCW2026-09-04
06971355350529BESDATAShenzhen BesdataTechnology Co., LTD.CCW2026-09-04
06971355350888BESDATAShenzhen BesdataTechnology Co., LTD.CCW2026-09-04
00190776427580MillenniumAvalign Technologies, Inc.CCW2026-08-26
00190776427597MillenniumAvalign Technologies, Inc.CCW2026-08-26
00190776427603MillenniumAvalign Technologies, Inc.CCW2026-08-26
00190776427610MillenniumAvalign Technologies, Inc.CCW2026-08-26
00198506094071ELMED INCORPORATEDELMED INCORPORATEDCCW2026-08-18
00190776422936MillenniumAvalign Technologies, Inc.CCW2026-08-03
14026704760548PILLINGTELEFLEX INCORPORATEDCCW2026-07-31
25056094503100PROACT SmoothlinePROACT MEDICAL LIMITEDCCW2026-07-31
25056094503117PROACT SmoothlinePROACT MEDICAL LIMITEDCCW2026-07-31
25056094503124PROACT SmoothlinePROACT MEDICAL LIMITEDCCW2026-07-31
25056094503131PROACT SmoothlinePROACT MEDICAL LIMITEDCCW2026-07-31
25056094503148PROACT SmoothlinePROACT MEDICAL LIMITEDCCW2026-07-31
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25056094503254PROACT SmoothlinePROACT MEDICAL LIMITEDCCW2026-07-31
25056094503261PROACT SmoothlinePROACT MEDICAL LIMITEDCCW2026-07-31