FDA.reportPublic FDA data

DELTRAN

Primary DI
H671AB24000
Brand
DELTRAN
Company
UTAH MEDICAL PRODUCTS, INC.
Model
PLUS ABC KIT
Catalog number
AB2-400
Device description
"Disposable Pressure Transducer System, 3cc/hr Flow Rate with Arterial Blood Collection System, 48/12"", Dual-Line, Micro Drip Chamber, 3cc Reservoir"
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
CBTArterial Blood Sampling Kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CBTArterial Blood Sampling KitAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
H671AB24001PackageHIBCC10In Commercial Distribution
H671AB24000PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
In-line arterial blood sampling setA collection of sterile devices designed to obtain an in-line arterial blood specimen while maintaining a closed system. It is a haemodynamic pressure monitoring and blood gas sampling device, typically designed for use with disposable/reusable pressure transducers, intended to connect to a central line/arterial catheter from which the blood specimen is obtained. Heparinized blood may be reinfused into the patient via the device to reduce fluid loss. This is a single-patient device that may be used short term (single-use) before being discarded.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Contacts#

Phone, Email table
PhoneEmail
800-533-4984customer@utahmed.com

Regulatory Flags#

DUNS number
094651270
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
H671303TT0CMITender Touch Cup303TT2016-09-23
H671303TTL0CMITender Touch Cup303TTL2016-09-23
H671404TT0CMITender Touch Cup404TT2016-09-23
H67141828050UMBILI-CATHSingle-Lumen Polyurethane41828052016-09-23
H67141835050UMBILI-CATHSingle-Lumen Polyurethane41835052016-09-23
H67141850050UMBILI-CATHSingle-Lumen Polyurethane41850052016-09-23
H67141865050UMBILI-CATHSingle-Lumen Polyurethane41865052016-09-23
H67142828050UMBILI-CATHDual-Lumen Polyurethane42828052016-09-23
H67142835050UMBILI-CATHDual-Lumen Polyurethane42835052016-09-23
H67142850050UMBILI-CATHDual-Lumen Polyurethane42850052016-09-23
H67143850050UMBILI-CATHTriple-Lumen Polyurethane43850052016-09-23
H671444FC0CMIFlex Cup444FC2016-09-23
H671505TT0CMIUltra Cup505TT2016-09-23
H671505TTL0CMIUltra Cup505TTL2016-09-23
H671506TTL0CMIUltra Cup506TTL2016-09-23
H671600TT0CMISecure Cup600TT2016-09-23
H671606TT0CMISecure Cup606TT2016-09-23
H671IUP4000INTRANPlusIUP-4002016-09-23
H671IUP4500INTRANPlusIUP-4502016-09-23
H671IUP5000INTRANPlusIUP-5002016-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10653160384540MEDLINEMEDLINE INDUSTRIES, INC.CBT2025-01-16
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10889483613122PulsetSUNMED, LLCCBT2024-05-17
10889483479407Atellica® VTR SyringesSUNMED, LLCCBT2023-06-30
10889483479414Atellica® VTR SyringesSUNMED, LLCCBT2023-06-30
10889483479469Atellica® VTR SyringesSUNMED, LLCCBT2023-06-30
10889483479476Atellica® VTR SyringesSUNMED, LLCCBT2023-06-30
10889483479483Atellica® VTR SyringesSUNMED, LLCCBT2023-06-30
10889483479490Atellica® VTR SyringesSUNMED, LLCCBT2023-06-30
10889483479506Atellica® VTR SyringesSUNMED, LLCCBT2023-06-30
10889483558249Pulset SUNMED, LLCCBT2023-06-30
10889483558256PulsetSUNMED, LLCCBT2023-06-30
10889483558263PulsetSUNMED, LLCCBT2023-06-30
10889483558270PulsetSUNMED, LLCCBT2023-06-30
10889483558287PulsetSUNMED, LLCCBT2023-06-30
10889483558294PulsetSUNMED, LLCCBT2023-06-30
10889483558300PulsetSUNMED, LLCCBT2023-06-30
10889483558317PulsetSUNMED, LLCCBT2023-06-30
10889483558331PulsetSUNMED, LLCCBT2023-06-30
10653160358329MEDLINEMEDLINE INDUSTRIES, INC.CBT2023-01-30
10653160357629MEDLINEMEDLINE INDUSTRIES, INC.CBT2022-12-20
10653160356677MEDLINEMEDLINE INDUSTRIES, INC.CBT2022-11-08
10653160355762MEDLINEMEDLINE INDUSTRIES, INC.CBT2022-10-17
10653160355472MEDLINEMEDLINE INDUSTRIES, INC.CBT2022-09-27
10653160355144CenturionCENTURION MEDICAL PRODUCTS CORPORATIONCBT2022-09-03
10653160355199MEDLINEMEDLINE INDUSTRIES, INC.CBT2022-09-03
10653160354338MEDLINEMEDLINE INDUSTRIES, INC.CBT2022-07-22