FDA.reportPublic FDA data

N/A

Primary DI
00840329833893
Brand
N/A
Company
BLACK & BLACK SURGICAL, INC.
Model
B89215
Catalog number
B89215
Device description
"15"" DUAL SPIKE INFILTRATION TUBING, WITH SILICONE INSERT, LATEX FREE, 10/BOX"
Published
2023-11-24
Public version status
New
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
GAZTubing, Noninvasive

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GAZTubing, NoninvasiveGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840329833893PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840329833893008403298338938403298338930840329833893

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
Radiation Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(770) 414-4880info@blackandblacksurgical.com

Regulatory Flags#

DUNS number
004382282
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840329811518N/AB79808B798082022-09-21
00840329811525N/AB79809B798092022-09-21
B089B784600Headlight CableB78460B784602016-07-29
B089B784640Headlight CableB78464B784642016-07-29
B089B797180Fiberoptic Cable B79718B797182016-07-29
B089B797190Fiberoptic Cable B79719B797192016-07-29
B089B797220Fiberoptic Cable B79722B797222016-07-29
B089B797230Fiberoptic Cable B79723B797232016-07-29
B089B797240Fiberoptic Cable B79724B797242016-07-29
B089B797250Fiberoptic Cable B79725B797252016-07-29
B089B797260Fiberoptic Cable B79726B797262016-07-29
B089B797270Fiberoptic Cable B79727B797272016-07-29
B089B797280Fiberoptic Cable B79728B797282016-07-29
B089B797590Fiberoptic Cable B79759B797592016-07-29
B089B797600Fiberoptic Cable B79760B797602016-07-29
B089B797610Fiberoptic Cable B79761B797612016-07-29
B089B797650Fiberoptic Cable B79765B797652016-07-29
B089B797660Fiberoptic Cable B79766B797662016-07-29
B089B797670Fiberoptic Cable B79767B797672016-07-29
B089B797680Fiberoptic Cable B79768B797682016-07-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10080196035151MEDLINEMEDLINE INDUSTRIES, INC.GAZ2025-04-25
10080196035168MEDLINEMEDLINE INDUSTRIES, INC.GAZ2025-04-25
10080196035229MEDLINEMEDLINE INDUSTRIES, INC.GAZ2025-04-25
10080196035243MEDLINEMEDLINE INDUSTRIES, INC.GAZ2025-04-25
10080196035250MEDLINEMEDLINE INDUSTRIES, INC.GAZ2025-04-25
10080196996063MEDLINEMEDLINE INDUSTRIES, INC.GAZ2025-04-25
10192253042917ArgyleCardinal Health 200, LLCGAZ2025-02-27
10192253043051ArgyleCardinal Health 200, LLCGAZ2025-02-27
14026704933119PLEUR-EVACTELEFLEX INCORPORATEDGAZ2024-11-18
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08809083944902EvaQMax LaparoBIOPROTECH INC.GAZ2024-08-28
08809083944919EvaQMax LaparoBIOPROTECH INC.GAZ2024-08-28
08809083944926EvaQMax LaparoBIOPROTECH INC.GAZ2024-08-28
20192253051909ArgyleCardinal Health 200, LLCGAZ2024-08-20
20192253051893ArgyleCardinal Health 200, LLCGAZ2024-08-19
20192253051916ArgyleCardinal Health 200, LLCGAZ2024-07-29
20192253051923ArgyleCardinal Health 200, LLCGAZ2024-07-29