FDA.report

V-Com

Primary DI
10860008554304
Brand
V-Com
Company
Sleepres, LLC
Model
1004
Published
2023-02-28
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
false

Related Records

Contact Domains

Product Codes

CodeName
BZAConnector, Airway (Extension)

Product Code Classifications

CodeDeviceSpecialtyClass
BZAConnector, Airway (Extension)Anesthesiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10860008554304PackageGS150In Commercial Distribution
00860008554307PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1086000855430410860008554304
00860008554307008600085543078600085543070860008554307

GMDN Terms

TermDefinition
Inspiratory/expiratory limb respiratory tubing, reusableA length of tube made of durable materials (e.g., rubber, silicone) intended to be used to conduct breathing gases towards or away from a patient during the respiratory cycle, typically during anaesthesia or ventilation [including continuous or bi-level positive airway pressure ventilation (CPAP or BPAP)]. It is intended to function as part of a breathing circuit and with other separate gas delivery devices (e.g., respiratory mask, connectors). This is a reusable device intended to be cleaned/disinfected prior to use.

Sterilization Methods

Method

Contacts

PhoneEmail
615-921-2406info@sleepres.com

Regulatory Flags

DUNS number
047606875
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
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 Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
06923980112799MindrayGaleMed Xiamen Co., Ltd.BZA2026-05-26
06944904007236MindrayGaleMed Xiamen Co., Ltd.BZA2026-05-26
16923980103206N/AGaleMed Xiamen Co., Ltd.BZA2026-05-25
20197344009807HUDSON RCIMEDLINE INDUSTRIES, INC.BZA2026-03-19
44710810084858N/AGALEMED CORPORATIONBZA2026-03-05
44710810086548N/AGALEMED CORPORATIONBZA2026-03-05
44710810102453N/AGALEMED CORPORATIONBZA2026-03-05
44710810104037N/AGALEMED CORPORATIONBZA2026-03-05
44710810110731N/AGALEMED CORPORATIONBZA2026-03-05
44710810082601N/AGALEMED CORPORATIONBZA2026-03-04
44710810083929N/AGALEMED CORPORATIONBZA2026-03-04
44710810086753N/AGALEMED CORPORATIONBZA2026-03-04
44710810087187N/AGALEMED CORPORATIONBZA2026-03-04
44710810104563N/AGALEMED CORPORATIONBZA2026-03-04
44710810107328N/AGALEMED CORPORATIONBZA2026-03-04
44710810111417N/AGALEMED CORPORATIONBZA2026-03-04
44710810115941N/AGALEMED CORPORATIONBZA2026-03-04
00619498004409HumidAirRESMED PTY LTDBZA2026-02-09
04048675034643Connector M34X1.5, 9/16Drägerwerk AG & Co. KGaABZA2026-02-04
04048675034735Adapter 9/16" to 6mmDrägerwerk AG & Co. KGaABZA2026-02-04
20197344012005HUDSON RCIMEDLINE INDUSTRIES, INC.BZA2026-01-23
20197344012432HUDSON RCIMEDLINE INDUSTRIES, INC.BZA2026-01-23
20197344012463HUDSON RCIMEDLINE INDUSTRIES, INC.BZA2026-01-23
20197344012593HUDSON RCIMEDLINE INDUSTRIES, INC.BZA2026-01-23
20197344042323HUDSON RCIMEDLINE INDUSTRIES, INC.BZA2026-01-23
46923980107748N/AGaleMed Xiamen Co., Ltd.BZA2025-12-24
46923980107281N/AGaleMed Xiamen Co., Ltd.BZA2025-12-23
20889483225254AirLife™SUNMED, LLCBZA2025-12-22
20889483225223Adapters/ConnectorsSUNMED, LLCBZA2025-12-18
20889483225278AirLife™SUNMED, LLCBZA2025-12-18