FDA.report

N/A

Primary DI
00840329811679
Brand
N/A
Company
BLACK & BLACK SURGICAL, INC.
Model
B89223
Catalog number
B89223
Device description
VITRUVIAN ASPIRATION STARTER KIT: - *FOR FIRST TIME ASPIRATOR PURCHASE ONLY*..
Published
2022-09-21
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
BYYTUBE, ASPIRATING, FLEXIBLE, CONNECTING

Product Code Classifications

CodeDeviceSpecialtyClass
BYYTube, Aspirating, Flexible, ConnectingGeneral Hospital2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840329811679PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840329811679008403298116798403298116790840329811679

GMDN Terms

TermDefinition
Secretion suction kitA collection of items intended for suctioning secretions from a patient; typically included are sterile gloves, a suction catheter, and a container for collecting the secretions. This is a single-use device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(770)414-4880info@blackandblacksurgical.com

Regulatory Flags

DUNS number
004382282
Device count
1
DM exempt
true
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
true

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00840329836795N/AB8XFIC-V-CC1218-LLB8XFIC-V-CC1218-LL2026-01-16
00840329837013N/AB8XIII-526L-AHB8XIII-526L-AH2026-01-16
00840329836375N/AB8XLVH-640L-AHB8XLVH-640L-AH2026-01-15
00840329836382N/AB8BX-DBAS-523 PWRB8BX-DBAS-523 PWR2026-01-15
00840329836399N/AB8BX-DBAS-530 PWRB8BX-DBAS-530 PWR2026-01-15
00840329836405N/AB8BX-DMER-523 PWRB8BX-DMER-523 PWR2026-01-15
00840329836412N/AB8XDBAS-530LB8XDBAS-530L2026-01-15
00840329836429N/AB8XSPA-1120-LLB8XSPA-1120-LL2026-01-15
00840329836443N/AB8XFAN-149-LLB8XFAN-149-LL2026-01-15
00840329836450N/AB8BX-BAS-432 PWR BARBB8BX-BAS-432 PWR BARB2026-01-15
00840329836467N/AB8XFIC-I-CC1810-LLB8XFIC-I-CC1810-LL2026-01-15
00840329836474N/AB8XSPA-CC1810-LLB8XSPA-CC1810-LL2026-01-15
00840329836481N/AB8XMLV-1215-LLB8XMLV-1215-LL2026-01-15
00840329836498N/AB8AX-MIII-432 MLRB8AX-MIII-432 MLR2026-01-15
00840329836504N/AB8XMER-215-SHB8XMER-215-SH2026-01-15
00840329836542N/AB8BX-BAS-540 ANG PWRB8BX-BAS-540 ANG PWR2026-01-15
00840329836559BLACK & BLACK SURGICAL, INC.B8BX-III-432 PWR RTB8BX-III-432 PWR RT2026-01-15

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