FDA.reportPublic FDA data

Dermapac, Inc.

Primary DI
00810102271341
Brand
Dermapac, Inc.
Company
Dermapac Inc.
Model
8774
Device description
Silicone Tubing 1/4" x 3/8" 6" long 1/pk
Published
2022-09-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
BYXTubing, Pressure And Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BYXTubing, Pressure And AccessoriesAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10810102271348PrimaryGS10
00810102271341Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081010227134810810102271348
00810102271341008101022713418101022713410810102271341

GMDN Terms#

Term, Definition table
TermDefinition
Suction/irrigation tubing, single-useA length of flexible noninvasive tube, typically made of synthetic polymer material(s), intended to interface between suction and/or irrigation devices (e.g., catheters, pumps, collection bottles) during a medical/surgical procedure (not dedicated to ophthalmic use); it might additionally be intended for use during reusable device reprocessing. The tubing may be provided in rolls from which required lengths are cut, or may be provided in predetermined lengths with connectors; it does not include additional associated items such as a clamp, spike, or bag (i.e., not a tubing set). This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
203-924-7148dermapac@msn.com

Regulatory Flags#

DUNS number
796088466
Device count
25
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
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
10810102271560Dermapac, Inc.99602022-07-12
10810102270112Dermapac, Inc.20362022-09-12
10810102270150Dermapac, Inc.20872022-09-12
10810102270235Dermapac, Inc.50082022-09-12
10810102270242Dermapac, Inc.5008-A2022-09-12
10810102271546Dermapac, Inc.99102022-09-12
10810102271553Dermapac, Inc.99112022-09-12
10810102271683Dermapac, Inc.99792022-09-12
10810102270006Dermapac, Inc.18032022-09-12
10810102270013Dermapac, Inc.18042022-09-12
10810102270020Dermapac, Inc.18052022-09-12
10810102270037Dermapac, Inc.18092022-09-12
10810102270044Dermapac, Inc.18102022-09-12
10810102270051Dermapac, Inc.18122022-09-12
10810102270068Dermapac, Inc.18142022-09-12
10810102270075Dermapac, Inc.18152022-09-12
10810102270082Dermapac, Inc.18322022-09-12
10810102270099Dermapac, Inc.18602022-09-12
10810102270105Dermapac, Inc.20342022-09-12
10810102270129Dermapac, Inc.20382022-09-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00607411919220Salter Labs® Oxygen TubingSALTER LABSBYX2026-06-09
00607411919237Salter Labs® Oxygen TubingSALTER LABSBYX2026-06-09
00607411919244Salter Labs® Oxygen TubingSALTER LABSBYX2026-06-09
00607411919251Salter Labs® Oxygen Tubing (MedTronic)SALTER LABSBYX2026-06-09
B929C4NI024FNNFP40Western Enterprises, IncWestern EnterprisesBYX2026-06-04
B929N4AIK240FHTFP40Western Enterprises, IncWestern EnterprisesBYX2026-06-04
B929N4OXW240FHTFP40Western Enterprises, IncWestern EnterprisesBYX2026-06-04
00848530108328Repair PartsSUNSET HEALTHCARE SOLUTIONS, INC.BYX2026-06-03
00848530108953Repair PartsSUNSET HEALTHCARE SOLUTIONS, INC.BYX2026-06-02
00848530108960Repair PartsSUNSET HEALTHCARE SOLUTIONS, INC.BYX2026-06-02
00848530108977Repair PartsSUNSET HEALTHCARE SOLUTIONS, INC.BYX2026-06-02
00848530109011Repair PartsSUNSET HEALTHCARE SOLUTIONS, INC.BYX2026-06-02
00848530109028Repair PartsSUNSET HEALTHCARE SOLUTIONS, INC.BYX2026-06-02
00848530109035Repair PartSUNSET HEALTHCARE SOLUTIONS, INC.BYX2026-06-02
00848530109073Repair PartsSUNSET HEALTHCARE SOLUTIONS, INC.BYX2026-06-02
10197344011230HUDSON RCIMEDLINE INDUSTRIES, INC.BYX2026-02-13
10197344011155HUDSON RCIMEDLINE INDUSTRIES, INC.BYX2026-02-12
10197344042401HUDSON RCIMEDLINE INDUSTRIES, INC.BYX2026-02-12
10885632467431HalyardOWENS & MINOR DISTRIBUTION, INC.BYX2026-01-29
10889483234402curaplex®SUNMED, LLCBYX2025-12-31
10889483225639AirLife™SUNMED, LLCBYX2025-12-18
10889483229279AirLife™SUNMED, LLCBYX2025-12-18
10197344162710MEDLINEMEDLINE INDUSTRIES, INC.BYX2025-12-12
10197344162727MEDLINEMEDLINE INDUSTRIES, INC.BYX2025-12-12
10197344011780HUDSON RCIMEDLINE INDUSTRIES, INC.BYX2025-12-03
10197344012237HUDSON RCIMEDLINE INDUSTRIES, INC.BYX2025-12-03
10197344012244HUDSON RCIMEDLINE INDUSTRIES, INC.BYX2025-12-03
10197344012572HUDSON RCIMEDLINE INDUSTRIES, INC.BYX2025-12-03
10197344042258HUDSON RCIMEDLINE INDUSTRIES, INC.BYX2025-12-03
10197344165315MEDLINEMEDLINE INDUSTRIES, INC.BYX2025-09-26