FDA.reportPublic FDA data

Coda®

Primary DI
00815965022253
Brand
Coda®
Company
LIFEGLOBAL GROUP, LLC
Model
CAFK-801
Catalog number
CAFK-801
Device description
Coda Aero 700/800 Semi-Annual Filter (Single)
Published
2016-09-28
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
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
MQGACCESSORY, ASSISTED REPRODUCTION

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MQGAccessory, Assisted ReproductionObstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K001486000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K001486000GENX CODA AIR PURIFICATION SYSTEM<Genx> Intl., Inc.2000-09-15MQG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00815965022253PackageGS12In Commercial Distribution
00815965022246PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00815965022253008159650222538159650222530815965022253
00815965022246008159650222468159650222460815965022246

GMDN Terms#

Term, Definition table
TermDefinition
Non-respiratory device ambient air filterA filter designed to be installed in a non-respiratory device to clean the ambient air that passes through it to facilitate device operation/management. It is composed of tightly woven materials which remove particulates/impurities and, depending on how the device is installed, reduce the concentration of impurities to or from the air. It is typically used in devices that draw in ambient air for use as part of their function (e.g., to cool electrical motors, liquidize air as in a flotation therapy bed, wash/disinfect surgical instruments), or devices that, having used the air as a drive gas, exhaust it into a room via the filter. After installation, this device cannot be reused.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)720-6375Sales@LifeGlobal.com

Regulatory Flags#

DUNS number
141732011
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00815965020358LifeGlobal® MediaLGPS-005LGPS-0052016-09-21
00815965020693LifeGlobal® MediaGHSA-005GHSA-0052016-09-21
00815965020754LifeGlobal® MediaLPVP-002LPVP-0022016-09-21
00815965020938Coda®CIPR-001CIPR-0012016-09-21
00815965020945Coda®CXBL-001CXBL-0012016-09-21
00815965020952Coda®CXGR-001CXGR-0012016-09-21
00815965020976Coda®GCIF-001GCIF-0012016-09-21
00815965021195Coda®GCAF-001GCAF-0012016-09-21
00815965021331LifeGlobal® MicropipetMPAH-30*01*MPAH-30*01*2016-09-21
00815965021348Coda®GCAF-701GCAF-7012016-09-21
00815965021355Coda®CAFK-901CAFK-9012016-09-21
00815965021867LifeGlobal® MicropipetMPBL-35B*01*MPBL-35B*01*2016-09-23
00815965021874LifeGlobal® MicropipetMPBL-25F-30*01*MPBL-25F-30*01*2016-09-23
00815965021881LifeGlobal® MicropipetMPBL-35F-30*01*MPBL-35F-30*01*2016-09-23
00815965021898LifeGlobal® MicropipetMPBL-35F-35*01*MPBL-35F-35*01*2016-09-23
00815965021904LifeGlobal® MicropipetMPHL-35*01*MPHL-35*01*2016-09-23
00815965021911LifeGlobal® MicropipetMPHL-30*01*MPHL-30*01*2016-09-23
00815965021928LifeGlobal® MicropipetMPIC-35*01*MPIC-35*01*2016-09-23
00815965021935LifeGlobal® MicropipetMPIC-30*01*MPIC-30*01*2016-09-23
00815965021942LifeGlobal® MicropipetMPIC-30L*01*MPIC-30L*01*2016-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05712714676123ES serverVitrolife A/SMQG2026-04-16
05712714676222EmbryoViewerVitrolife A/SMQG2026-04-16
04779041940144Dish for MIRI TLESCO MEDICAL TECHNOLOGIES UABMQG2026-01-15
04779041940212Multiroom IVF incubatorESCO MEDICAL TECHNOLOGIES UABMQG2026-01-15
04779041940229Multiroom IVF incubatorESCO MEDICAL TECHNOLOGIES UABMQG2026-01-15
04779041940298MIRI Time-Lapse IncubatorESCO MEDICAL TECHNOLOGIES UABMQG2026-01-14
06975183900185Harioculture TL-16 Time-lapse IncubatorHua Yue Medical Technology Co., Ltd.MQG2025-09-30
06975183900192Time-lapse Incubator Capacity Expansion ModuleHua Yue Medical Technology Co., Ltd.MQG2025-09-30
05060554120024CODARESEARCH INSTRUMENTS LIMITEDMQG2024-09-20
16975737430110MetiecWuhan Huchuang Union Technology Co., Ltd.MQG2024-05-27
06975737430113MetiecWuhan Huchuang Union Technology Co., Ltd.MQG2024-05-27
06975737430106MetiecWuhan Huchuang Union Technology Co., Ltd.MQG2024-05-27
26975737430001MetiecWuhan Huchuang Union Technology Co., Ltd.MQG2024-05-27
00370275091011FS DispenserForward Science Technologies LLCMQG2024-02-21
05055270911643RocketROCKET MEDICAL PLCMQG2023-11-03
05055270984524RocketROCKET MEDICAL PLCMQG2023-10-31
05055270909060RocketROCKET MEDICAL PLCMQG2023-10-30
05055270909329RocketROCKET MEDICAL PLCMQG2023-10-30
05055270984463RocketROCKET MEDICAL PLCMQG2023-10-30
05055270911582RocketROCKET MEDICAL PLCMQG2023-10-24
00827002444294COOKWILLIAM A. COOK AUSTRALIA PTY. LTD.MQG2023-08-15
03661532000318STERILE 0.5 ML CBS STRAW FOR SPERM WITH COTTON PLUG / 4x5CRYO BIO SYSTEMMQG2020-11-03
03661532000349STERILE CBS 0.5 ML STRAW FOR SPERM WITH RED COTTON PLUG / 5 x20CRYO BIO SYSTEMMQG2020-11-03
03661532000356STERILE CBS 0.5 ML STRAW FOR SPERM WITH YELLOW COTTON PLUG / 5 X 20CRYO BIO SYSTEMMQG2020-11-03
03661532000363STERILE CBS 0.5 ML STRAW FOR SPERM WITH GREEN COTTON PLUG / 5 X 20CRYO BIO SYSTEMMQG2020-11-03
03661532000370STERILE CBS 0.5 ML STRAW FOR SPERM WITH BLUE COTTON PLUG / 5 X 20CRYO BIO SYSTEMMQG2020-11-03
03661532000479STERILE 0.3 ML CBS STRAW WITH WHITE JACKET AND RED FLEXIBLE ROD / BLISTER 5X15CRYO BIO SYSTEMMQG2020-11-03
03661532000486STERILE 0.3 ML CBS STRAW WITH WHITE JACKET AND WHITE FLEXIBLE ROD / BLISTER 5X15CRYO BIO SYSTEMMQG2020-11-03
03661532000493STERILE 0.3 ML CBS STRAW WITH WHITE JACKET AND YELLOW FLEXIBLE ROD / BLISTER 5X1CRYO BIO SYSTEMMQG2020-11-03
03661532000509STERILE 0.3 ML CBS STRAW WITH WHITE JACKET AND BLUE FLEXIBLE ROD / BLISTER 5X15CRYO BIO SYSTEMMQG2020-11-03